Trial · NCT02531217
Safety, Tolerability, Pharmacokinetics (PK), and Activity of ATYR1940 in Participants With Muscular Dystrophy - Study Extension
NCT02531217, Phase 1, Phase 2, Completed, aTyr Pharma, Inc.; results first posted 2023-08-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety, Tolerability, Pharmacokinetics (PK), and Activity of ATYR1940 in Participants With Muscular Dystrophy - Study Extension. Trials, record NCT02531217. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02531217
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety, Tolerability, Pharmacokinetics (PK), and Activity of ATYR1940 in Participants With Muscular Dystrophy - Study Extension
- NCT number
- NCT02531217
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 9 participants, actual
- Lead sponsor
- aTyr Pharma, Inc.
- Conditions
- Facioscapulohumeral Muscular Dystrophy
- Interventions
- ATYR1940
- First posted
- 2015-08-24
- Last updated
- 2023-08-18
- Other registries' IDs
- eudract:2015-001912-36
- Results first posted
- 2023-08-18
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Up to End of Study (up to Week 36) | TEAEs were defined as adverse events (AEs) with an onset following administration of the first dose of study drug. AEs ware defined as any untoward medical occurrence in a participant administered study drug and that does not necessarily have a causal relationship with the study drug. Worsening of a pre-existing medical condition should have been considered an AE if there was either an increase in severity, frequency, or duration of the condition or an association with significantly worse outcomes. SAEs were defined as any AE that, in the view of either the Investigator or Sponsor, resulted in any of the following outcomes as fatal, life-threatening, required in-participant hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, an important medical event. A summary of all SAEs and Other AEs (nonserious) regardless of causality is located in 'Reported Adverse Events' Section. |
| Primary | Number of Participants With Clinically Significant Physical Examination Abnormality | Up to End of Study (up to Week 36) | Body systems that were evaluated during the physical examination included general appearance, head, eyes, ears, nose, throat, cardiovascular system, respiratory system, gastrointestinal system (abdomen), lymphatic system, musculoskeletal system, skin, psychiatric, and neurologic. Neurologic examination included assessment of mental status, memory, cranial nerves, motor function, reflexes, and sensory testing. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section. |
| Primary | Number of Participants With a Vital Sign-Related Event Resulting in a TEAE | Up to End of Study (up to Week 36) | The vital sign parameters that were evaluated included blood pressure, pulse and respiration rates, and body temperature. Vital signs abnormalities that were considered by the Investigator to be clinically significant were reported as AEs if the finding represented a change from baseline. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section. |
| Primary | Number of Participants With a Clinically Significant Pulmonary Function Event Resulting in a TEAE | Up to End of Study (up to Week 36) | Pulmonary evaluations included pulmonary function tests. Clinically significant changes were to be reported as adverse events. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section. |
| Primary | Number of Participants With a Clinical Laboratory Abnormality Resulting in an AE | Up to End of Study (Up to Week 36) | Laboratory parameters included hematology (hematocrit, hemoglobin, red blood cell count, white blood cell count with differential \[neutrophils, lymphocytes, monocytes, eosinophils, basophils\], and platelet count); serum chemistries (blood urea nitrogen, creatinine, total bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transferase, alkaline phosphatase, total protein, sodium, potassium, bicarbonate, calcium, chloride, magnesium, inorganic phosphate, creatine kinase, lactate dehydrogenase, C-reactive protein, troponin, myoglobin, insulin-like growth factor 1, and cholesterol \[nonfasting\]); and urinalysis (color, pH, specific gravity, protein, glucose, ketones, and blood). Clinically significant laboratory abnormalities were based upon Investigator's discretion. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Up to End of Study (up to Week 36) | ITT analysis set included all participants who were randomized and received at least 1 dose (full or partial) of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Physical Examination Abnormality | Up to End of Study (up to Week 36) | ITT analysis set included all participants who were randomized and received at least 1 dose (full or partial) of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With a Vital Sign-Related Event Resulting in a TEAE | Up to End of Study (up to Week 36) | ITT analysis set included all participants who were randomized and received at least 1 dose (full or partial) of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With a Clinically Significant Pulmonary Function Event Resulting in a TEAE | Up to End of Study (up to Week 36) | ITT analysis set included all participants who were randomized and received at least 1 dose (full or partial) of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With a Clinical Laboratory Abnormality Resulting in an AE | Up to End of Study (Up to Week 36) | ITT analysis set included all participants who were randomized and received at least 1 dose (full or partial) of study drug. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | ATYR1940 | TEAEs | 9 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | ATYR1940 | SAEs | 0 | Participants | |
| Number of Participants With Clinically Significant Physical Examination Abnormality | ATYR1940 | 4 | Participants | ||
| Number of Participants With a Vital Sign-Related Event Resulting in a TEAE | ATYR1940 | 0 | Participants | ||
| Number of Participants With a Clinically Significant Pulmonary Function Event Resulting in a TEAE | ATYR1940 | 0 | Participants | ||
| Number of Participants With a Clinical Laboratory Abnormality Resulting in an AE | ATYR1940 | 3 | Participants |
Source ClinicalTrials.gov
Participant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ATYR1940 | 9 | |
| Overall Study | Received at Least One Dose of Study Drug | ATYR1940 | 9 | |
| Overall Study | COMPLETED | ATYR1940 | 9 | |
| Overall Study | NOT COMPLETED | ATYR1940 | 0 |
Source ClinicalTrials.gov
Adverse events54
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 | Ear Pain | Ear and labyrinth disorders | ATYR1940 | 1 | 9 | |
| other | Vertigo | Ear and labyrinth disorders | ATYR1940 | 1 | 9 | |
| other | Abdominal Pain Upper | Gastrointestinal disorders | ATYR1940 | 2 | 9 | |
| other | Abdominal Pain Lower | Gastrointestinal disorders | ATYR1940 | 1 | 9 | |
| other | Constipation | Gastrointestinal disorders | ATYR1940 | 1 | 9 | |
| other | Diarrhoea | Gastrointestinal disorders | ATYR1940 | 2 | 9 | |
| other | Flatulence | Gastrointestinal disorders | ATYR1940 | 1 | 9 | |
| other | Nausea | Gastrointestinal disorders | ATYR1940 | 1 | 9 | |
| other | Stomatitis | Gastrointestinal disorders | ATYR1940 | 1 | 9 | |
| other | Toothache | Gastrointestinal disorders | ATYR1940 | 1 | 9 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ATYR1940 | ||
| Total, other adverse events | ATYR1940 | 9 | 9 |
| Total, serious adverse events | ATYR1940 | 0 | 9 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT02531217
GET https://conductscience.org/api/trials/v1/NCT02531217/events?page=2