Trial · NCT02691702
Multiple Dose Study Of BIIB118 (PF-05251749) In Healthy Volunteers
NCT02691702, Phase 1, Completed, Biogen; results first posted 2018-10-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Multiple Dose Study Of BIIB118 (PF-05251749) In Healthy Volunteers. Trials, record NCT02691702. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02691702
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Multiple Dose Study Of BIIB118 (PF-05251749) In Healthy Volunteers
- NCT number
- NCT02691702
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 97 participants, actual
- Lead sponsor
- Biogen
- Conditions
- Healthy Adult Subjects, Healthy Elderly Subjects
- Interventions
- BIIB118, Melatonin
- First posted
- 2016-02-25
- Last updated
- 2021-02-17
- Results first posted
- 2018-10-15
- Limitations and caveats
From Parts A and B, it was deemed that safety, tolerability, PK and PD objectives were met, so Part C was not conducted. Because of limited saliva sampling duration (06:00 PM to 12:00 AM), DLMO observation(s) beyond midnight could not be quantified.
Source ClinicalTrials.gov
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline for Bond and Lader Visual Analogue Scale (BL-VAS) on Days 1, 4, 7, 10, 14, 15 and 16 - Alertness | Baseline (0h on Day 1), Day 1 (2h), Day 4 (1.5h), Day 7 (0h, 2h), Day 10 (1.5h), Day 14 (0h, 2h), Day 15 (0h) and Day 16 (0h). | The Bond and Lader Visual Analogue Scales (VAS) monitored the subjective mood of each participant on 16 mood scales. Participants were asked to indicate on the VAS scale ranging from 0 to 100 mm about how they felt at the moment the scale was administered (example, alert/drowsy; calm/excited; content/tensed). The individual responses from the 16 mood scales were then combined to make three affective dimensions/subscales a) alertness (average of 9 items \[total range 0 to 100, where each item is ordered so that higher scores indicated more alertness\]), b) mood (average of 2 items \[total range 0 to 100, where higher scores indicated elevated mood\]), and c) calmness (average of 5 items \[total range 0 to 100, where higher scores indicated more calmness\]). Baseline is defined as the last available recording prior to dosing on Day 1. |
| Primary | Change From Baseline for Bond and Lader Visual Analogue Scale (BL-VAS) on Days 1, 4, 7, 10, 14, 15 and 16 - Calmness | Baseline (0h on Day 1), Day 1 (2h), Day 4 (1.5h), Day 7 (0h, 2h), Day 10 (1.5h), Day 14 (0h, 2h), Day 15 (0h) and Day 16 (0h). | The Bond and Lader Visual Analogue Scales (VAS) monitored the subjective mood of each participant on 16 mood scales. Participants were asked to indicate on the VAS scale ranging from 0 to 100 mm about how they felt at the moment the scale was administered (example, alert/drowsy; calm/excited; content/tensed). The individual responses from the 16 mood scales were then combined to make three affective dimensions/subscales a) alertness (average of 9 items \[total range 0 to 100, where each item is ordered so that higher scores indicated more alertness\]), b) mood (average of 2 items \[total range 0 to 100, where higher scores indicated elevated mood\]), and c) calmness (average of 5 items \[total range 0 to 100, where higher scores indicated more calmness\]). Baseline is defined as the last available recording prior to dosing on Day 1. |
| Primary | Change From Baseline for Bond and Lader Visual Analogue Scale (BL-VAS) on Days 1, 4, 7, 10, 14, 15 and 16- Mood | Baseline (0h on Day 1), Day 1 (2h), Day 4 (1.5h), Day 7 (0h, 2h), Day 10 (1.5h), Day 14 (0h, 2h), Day 15 (0h) and Day 16 (0h). | The Bond and Lader Visual Analogue Scales (VAS) monitored the subjective mood of each participant on 16 mood scales. Participants were asked to indicate on the VAS scale ranging from 0 to 100 mm about how they felt at the moment the scale was administered (example, alert/drowsy; calm/excited; content/tensed). The individual responses from the 16 mood scales were then combined to make three affective dimensions/subscales a) alertness (average of 9 items \[total range 0 to 100, where each item is ordered so that higher scores indicated more alertness\]), b) mood (average of 2 items \[total range 0 to 100, where higher scores indicated elevated mood\]), and c) calmness (average of 5 items \[total range 0 to 100, where higher scores indicated more calmness\]). Baseline is defined as the last available recording prior to dosing on Day 1. |
| Primary | Number of Participants With New Onset and Worsening of Post-baseline Suicidality for Columbia Suicide Severity Rating Scale (C-SSRS) | Days 0, 7, 14, 16, and follow-up visit (28 calender days after the last dose of investigational product on Day 14). | The C-SSRS was an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced any of the following 1: completed suicide, 2: suicide attempt (response of "yes" on "actual attempt"), 3: preparatory acts toward imminent suicidal behavior ("yes" on "aborted attempt", "interrupted attempt", "preparatory acts or behavior"), 4: any suicidal behavior or ideation, suicidal ideation ("yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent"), 7: self-injurious behavior, no suicidal intent ("yes" on "has participant engaged in non-suicidal self-injurious behavior"). The new onset and worsening of post-baseline suicidality for C-SSRS was reported. |
| Primary | Number of Participants With Treatment-Emergent Adverse Events (AEs) (All Causalities) | Day 1 to follow-up visit (28 calendar days after the last dose of investigational product on Day 14). | An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. |
| Primary | Number of Participants With Treatment-Emergent Adverse Events (AEs) (Treatment Related) | Day 1 to follow-up visit (28 calendar days after the last dose of investigational product on Day 14). | An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; The event has a causal relationship with the treatment or usage. |
| Primary | Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) | Day 1 to follow-up visit (28 calendar days after the last dose of investigational product on Day 14). | The laboratory test included: hematology (hemoglobin, hematocrit, red blood cell count, MCV, MCH, MCHC, platelets, white blood cell count, absolute lymphocytes, absolute total neutrophils, absolute basophils, absolute eosinophils and absolute monocytes), coagulation (PPT, prothrombin, PT international, ratio and fibrinogen, liver function(total bilirubin, direct bilirubin, aspartate, AST, Alanine, ALT, gamma GT, alkaline phosphatase, total protein and albumin), renal function (blood urea nitrogen, creatinine, HDL cholesterol, LDL cholesterol, triglycerides), Electrolytes (sodium, potassium, chloride, calcium, phosphate, venous bicarbonate), clinical chemistry (glucose, creatinine kinase), urinalysis dipstick (urine PH, urine glucose, urine ketones, urine protein, urine blood, urine urobilinogen, urine nitrite, urine leukocyte, esterase), urinalysis microscopy (urine RBC, urine WBC, urine casts, urine bacteria), miscellaneous (absolute lymphocyte marker CD4, CD8, CD19) |
| Primary | Number of Participants With Vital Signs Data Meeting Categorical Criteria (Absolute Values) | Day 1 to follow-up visit (28 calendar days after the last dose of investigational product on Day 14). | Number of participants with vital signs data of absolute values meeting categorical criteria was reported as following: (1) Supine systolic BP \< 90 mmHg; (2) Supine Diastolic BP \< 50 mmHg; (3) Supine Pulse Rate \< 40 BPM ; (4) Supine Pulse Rate \> 120 BPM. |
| Primary | Number of Participants With Vital Signs Data Meeting Categorical Criteria (Increases From Baseline) | Day 1 to follow-up visit (28 calendar days after the last dose of investigational product on Day 14). | Number of participants with vital signs data of increase from baseline meeting the following criteria was reported: Criterion A: maximum increase from baseline in supine systolic BP \>= 30 mmHg; Criterion B: maximum increase from baseline in supine diastolic BP \>= 20 mmHg. Baseline was defined as the last available recording prior to dosing. |
| Primary | Number of Participants With Vital Signs Data Meeting Categorical Criteria (Decrease From Baseline) | Day 1 to follow-up visit (28 calendar days after the last dose of investigational product on Day 14). | Number of participants with vital signs data of increase from baseline meeting the following criteria was reported: Criterion A: maximum decrease from baseline in supine systolic BP \>= 30 mmHg; Criterion B: maximum decrease from baseline in supine diastolic BP \>= 20 mmHg. Baseline was defined as the last available recording prior to dosing. |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 registered outcomesOutcomes29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline for Bond and Lader Visual Analogue Scale (BL-VAS) on Days 1, 4, 7, 10, 14, 15 and 16 - Alertness | Baseline (0h on Day 1), Day 1 (2h), Day 4 (1.5h), Day 7 (0h, 2h), Day 10 (1.5h), Day 14 (0h, 2h), Day 15 (0h) and Day 16 (0h). | The safety analysis set included all participants who received at least 1 dose of study treatment. | Units on a scale | MEAN |
| PRIMARY | Change From Baseline for Bond and Lader Visual Analogue Scale (BL-VAS) on Days 1, 4, 7, 10, 14, 15 and 16 - Calmness | Baseline (0h on Day 1), Day 1 (2h), Day 4 (1.5h), Day 7 (0h, 2h), Day 10 (1.5h), Day 14 (0h, 2h), Day 15 (0h) and Day 16 (0h). | The safety analysis set included all participants who received at least 1 dose of study treatment. | Units on a scale | MEAN |
| PRIMARY | Change From Baseline for Bond and Lader Visual Analogue Scale (BL-VAS) on Days 1, 4, 7, 10, 14, 15 and 16- Mood | Baseline (0h on Day 1), Day 1 (2h), Day 4 (1.5h), Day 7 (0h, 2h), Day 10 (1.5h), Day 14 (0h, 2h), Day 15 (0h) and Day 16 (0h). | The safety analysis set included all participants who received at least 1 dose of study treatment. | Units on a scale | MEAN |
| PRIMARY | Number of Participants With New Onset and Worsening of Post-baseline Suicidality for Columbia Suicide Severity Rating Scale (C-SSRS) | Days 0, 7, 14, 16, and follow-up visit (28 calender days after the last dose of investigational product on Day 14). | The safety analysis set included all participants who received at least 1 dose of study treatment. | Participants | NUMBER |
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (AEs) (All Causalities) | Day 1 to follow-up visit (28 calendar days after the last dose of investigational product on Day 14). | The safety analysis set included all participants who received at least 1 dose of study treatment. | Participants | NUMBER |
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (AEs) (Treatment Related) | Day 1 to follow-up visit (28 calendar days after the last dose of investigational product on Day 14). | The safety analysis set included all participants who received at least 1 dose of study treatment. | Participants | NUMBER |
| PRIMARY | Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) | Day 1 to follow-up visit (28 calendar days after the last dose of investigational product on Day 14). | The safety analysis set included all participants who received at least 1 dose of study treatment. | Participants | NUMBER |
| PRIMARY | Number of Participants With Vital Signs Data Meeting Categorical Criteria (Absolute Values) | Day 1 to follow-up visit (28 calendar days after the last dose of investigational product on Day 14). | The safety analysis set included all participants who received at least 1 dose of study treatment. | Participants | NUMBER |
| PRIMARY | Number of Participants With Vital Signs Data Meeting Categorical Criteria (Increases From Baseline) | Day 1 to follow-up visit (28 calendar days after the last dose of investigational product on Day 14). | The safety analysis set included all participants who received at least 1 dose of study treatment. | Participants | NUMBER |
| PRIMARY | Number of Participants With Vital Signs Data Meeting Categorical Criteria (Decrease From Baseline) | Day 1 to follow-up visit (28 calendar days after the last dose of investigational product on Day 14). | The safety analysis set included all participants who received at least 1 dose of study treatment. | Participants | NUMBER |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 outcomesResults by group865
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline for Bond and Lader Visual Analogue Scale (BL-VAS) on Days 1, 4, 7, 10, 14, 15 and 16 - Alertness | Placebo (Part A) | Day 1 (2h) | 2.16 | Standard Deviation 7.405 | Units on a scale |
| Change From Baseline for Bond and Lader Visual Analogue Scale (BL-VAS) on Days 1, 4, 7, 10, 14, 15 and 16 - Alertness | Melatonin 0.5 mg PM (Part A) | Day 1 (2h) | 7.50 | Standard Deviation 8.043 | Units on a scale |
| Change From Baseline for Bond and Lader Visual Analogue Scale (BL-VAS) on Days 1, 4, 7, 10, 14, 15 and 16 - Alertness | PF-05251749 50 mg AM (Part A) | Day 1 (2h) | 6.71 | Standard Deviation 12.314 | Units on a scale |
| Change From Baseline for Bond and Lader Visual Analogue Scale (BL-VAS) on Days 1, 4, 7, 10, 14, 15 and 16 - Alertness | PF-05251749 100 mg AM (Part A) | Day 1 (2h) | 3.50 | Standard Deviation 10.071 | Units on a scale |
| Change From Baseline for Bond and Lader Visual Analogue Scale (BL-VAS) on Days 1, 4, 7, 10, 14, 15 and 16 - Alertness | PF-05251749 200 mg AM (Part A) | Day 1 (2h) | 4.58 | Standard Deviation 9.472 | Units on a scale |
| Change From Baseline for Bond and Lader Visual Analogue Scale (BL-VAS) on Days 1, 4, 7, 10, 14, 15 and 16 - Alertness | PF-05251749 400 mg AM (Part A) | Day 1 (2h) | 4.05 | Standard Deviation 6.038 | Units on a scale |
| Change From Baseline for Bond and Lader Visual Analogue Scale (BL-VAS) on Days 1, 4, 7, 10, 14, 15 and 16 - Alertness | PF-05251749 750 mg AM (Part A) | Day 1 (2h) | 1.49 | Standard Deviation 11.514 | Units on a scale |
| Change From Baseline for Bond and Lader Visual Analogue Scale (BL-VAS) on Days 1, 4, 7, 10, 14, 15 and 16 - Alertness | Placebo (Part B) | Day 1 (2h) | -0.08 | Standard Deviation 6.382 | Units on a scale |
| Change From Baseline for Bond and Lader Visual Analogue Scale (BL-VAS) on Days 1, 4, 7, 10, 14, 15 and 16 - Alertness | PF-05251749 50 mg PM (Part B) | Day 1 (2h) | -2.83 | Standard Deviation 7.314 | Units on a scale |
| Change From Baseline for Bond and Lader Visual Analogue Scale (BL-VAS) on Days 1, 4, 7, 10, 14, 15 and 16 - Alertness | PF-05251749 200 mg PM (Part B) | Day 1 (2h) | -6.04 | Standard Deviation 10.085 | Units on a scale |
1 to 10 of 865Source ClinicalTrials.gov
See all 865 results by groupParticipant flow33
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo (Part A) | 10 | |
| Overall Study | STARTED | Melatonin 0.5 mg PM (Part A) | 11 | |
| Overall Study | STARTED | PF-05251749 50 mg AM (Part A) | 8 | |
| Overall Study | STARTED | PF-05251749 100 mg AM (Part A) | 8 | |
| Overall Study | STARTED | PF-05251749 200 mg AM (Part A) | 8 | |
| Overall Study | STARTED | PF-05251749 400 mg AM (Part A) | 8 | |
| Overall Study | STARTED | PF-05251749 750 mg AM (Part A) | 8 | |
| Overall Study | STARTED | Placebo (Part B) | 12 | |
| Overall Study | STARTED | PF-05251749 50 mg PM (Part B) | 8 | |
| Overall Study | STARTED | PF-05251749 200 mg PM (Part B) | 8 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 participant flowAdverse events330
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Thrombocytosis | Blood and lymphatic system disorders | Placebo (Part A) | 0 | 10 | |
| other | Thrombocytosis | Blood and lymphatic system disorders | Melatonin 0.5 mg PM (Part A) | 0 | 11 | |
| other | Thrombocytosis | Blood and lymphatic system disorders | PF-05251749 50 mg AM (Part A) | 0 | 8 | |
| other | Thrombocytosis | Blood and lymphatic system disorders | PF-05251749 100 mg AM (Part A) | 0 | 8 | |
| other | Thrombocytosis | Blood and lymphatic system disorders | PF-05251749 200 mg AM (Part A) | 0 | 8 | |
| other | Thrombocytosis | Blood and lymphatic system disorders | PF-05251749 400 mg AM (Part A) | 0 | 8 | |
| other | Thrombocytosis | Blood and lymphatic system disorders | PF-05251749 750 mg AM (Part A) | 1 | 8 | |
| other | Thrombocytosis | Blood and lymphatic system disorders | Placebo (Part B) | 0 | 12 | |
| other | Thrombocytosis | Blood and lymphatic system disorders | PF-05251749 50 mg PM (Part B) | 0 | 8 | |
| other | Thrombocytosis | Blood and lymphatic system disorders | PF-05251749 200 mg PM (Part B) | 0 | 8 |
1 to 10 of 330Source ClinicalTrials.gov
See all 330 adverse eventsAdverse event totals33
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo (Part A) | 0 | 10 |
| Total, all-cause mortality | Melatonin 0.5 mg PM (Part A) | 0 | 11 |
| Total, all-cause mortality | PF-05251749 50 mg AM (Part A) | 0 | 8 |
| Total, all-cause mortality | PF-05251749 100 mg AM (Part A) | 0 | 8 |
| Total, all-cause mortality | PF-05251749 200 mg AM (Part A) | 0 | 8 |
| Total, all-cause mortality | PF-05251749 400 mg AM (Part A) | 0 | 8 |
| Total, all-cause mortality | PF-05251749 750 mg AM (Part A) | 0 | 8 |
| Total, all-cause mortality | Placebo (Part B) | 0 | 12 |
| Total, all-cause mortality | PF-05251749 50 mg PM (Part B) | 0 | 8 |
| Total, all-cause mortality | PF-05251749 200 mg PM (Part B) | 0 | 8 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35730131 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02691702
GET https://conductscience.org/api/trials/v1/NCT02691702/registered?page=2