Trial · NCT03866434
Study to Evaluate the Effect of Omeprazole on the Pharmacokinetics of SPD422 (Anagrelide Hydrochloride) in Healthy Adult Participants
NCT03866434, Phase 1, Completed, Shire; results first posted 2020-04-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate the Effect of Omeprazole on the Pharmacokinetics of SPD422 (Anagrelide Hydrochloride) in Healthy Adult Participants. Trials, record NCT03866434. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03866434
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Effect of Omeprazole on the Pharmacokinetics of SPD422 (Anagrelide Hydrochloride) in Healthy Adult Participants
- NCT number
- NCT03866434
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 20 participants, actual
- Lead sponsor
- Shire
- Conditions
- Healthy Volunteers
- Interventions
- SPD422, Omeprazole
- First posted
- 2019-03-07
- Last updated
- 2021-06-15
- Results first posted
- 2020-04-24
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Observed Plasma Concentration (Cmax) of Anagrelide (SPD422) | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12 hours on Day 1 and Day 8, 24 hours on Day 8 | Cmax of Anagrelide (SPD422) on Day 1 and Day 8 was reported. For PK outcome measures the reporting groups were split based on administration of Anagrelide alone (Day 1) and Anagrelide in combination with Omeprazole (Day 8) to provide statistical comparison in this single arm study. |
| Primary | Maximum Observed Plasma Concentration (Cmax) of 3-Hydroxy (OH)-Anagrelide (Active Metabolite of Anagrelide) | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12 hours on Day 1 and Day 8, 24 hours on Day 8 | Cmax of 3-OH-Anagrelide (Active Metabolite of Anagrelide) on Day 1 and Day 8 was reported. For PK outcome measures the reporting groups were split based on administration of Anagrelide alone (Day 1) and Anagrelide in combination with Omeprazole (Day 8) to provide statistical comparison in this single arm study. |
| Primary | Area Under the Concentration Versus Time Curve From Zero to Last Time Point (AUC[0-t]) of Anagrelide (SPD422) in Plasma | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12 hours on Day 1 and Day 8, 24 hours on Day 8 | AUC(0-t) of Anagrelide (SPD422) in plasma on Day 1 and Day 8 was reported. For PK outcome measures the reporting groups were split based on administration of Anagrelide alone (Day 1) and Anagrelide in combination with Omeprazole (Day 8) to provide statistical comparison in this single arm study. |
| Primary | Area Under the Concentration Versus Time Curve From Zero to Last Time Point (AUC[0-t]) of 3-Hydroxy (OH)-Anagrelide (Active Metabolite of Anagrelide) in Plasma | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12 hours on Day 1 and Day 8, 24 hours on Day 8 | AUC(0-t) of 3-OH-Anagrelide (Active Metabolite of Anagrelide) in Plasma on Day 1 and Day 8 was reported. For PK outcome measures the reporting groups were split based on administration of Anagrelide alone (Day 1) and Anagrelide in combination with Omeprazole (Day 8) to provide statistical comparison in this single arm study. |
| Primary | Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-infinity]) of Anagrelide (SPD422) in Plasma | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12 hours on Day 1 and Day 8, 24 hours on Day 8 | AUC(0-infinity) of Anagrelide (SPD422) in plasma on Day 1 and Day 8 was reported. For PK outcome measures the reporting groups were split based on administration of Anagrelide alone (Day 1) and Anagrelide in combination with Omeprazole (Day 8) to provide statistical comparison in this single arm study. |
| Primary | Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-infinity]) of 3-Hydroxy (OH)-Anagrelide (Active Metabolite of Anagrelide) in Plasma | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12 hours on Day 1 and Day 8, 24 hours on Day 8 | AUC(0-infinity) of 3-OH-Anagrelide (Active Metabolite of Anagrelide) in Plasma on Day 1 and Day 8 was reported. For PK outcome measures the reporting groups were split based on administration of Anagrelide alone (Day 1) and Anagrelide in combination with Omeprazole (Day 8) to provide statistical comparison in this single arm study. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | From start of study drug administration up to follow-up (up to Day 18) | An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily had a causal relationship with this treatment. An AE was considered a TEAE if it started on or after dosing on Day 1 or if it started before dosing on Day 1 but increased in severity on or after dosing on Day 1 through the end of the study. Number of participants with TEAEs and TESAEs were reported. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Observed Plasma Concentration (Cmax) of Anagrelide (SPD422) | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12 hours on Day 1 and Day 8, 24 hours on Day 8 | Pharmacokinetic (PK) set included all participants who received at least 1 dose of investigational product (anagrelide or omeprazole) and had at least 1 measurable post dose plasma concentration. | nanogram per milliliter (ng/mL) | MEAN |
| PRIMARY | Maximum Observed Plasma Concentration (Cmax) of 3-Hydroxy (OH)-Anagrelide (Active Metabolite of Anagrelide) | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12 hours on Day 1 and Day 8, 24 hours on Day 8 | PK set included all participants who received at least 1 dose of investigational product (anagrelide or omeprazole) and had at least 1 measurable post dose plasma concentration. | ng/mL | MEAN |
| PRIMARY | Area Under the Concentration Versus Time Curve From Zero to Last Time Point (AUC[0-t]) of Anagrelide (SPD422) in Plasma | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12 hours on Day 1 and Day 8, 24 hours on Day 8 | PK set included all participants who received at least 1 dose of investigational product (anagrelide or omeprazole) and had at least 1 measurable post dose plasma concentration. | hour*nanogram per milliliter (h*ng/mL) | MEAN |
| PRIMARY | Area Under the Concentration Versus Time Curve From Zero to Last Time Point (AUC[0-t]) of 3-Hydroxy (OH)-Anagrelide (Active Metabolite of Anagrelide) in Plasma | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12 hours on Day 1 and Day 8, 24 hours on Day 8 | PK set included all participants who received at least 1 dose of investigational product (anagrelide or omeprazole) and had at least 1 measurable post dose plasma concentration. | h*ng/mL | MEAN |
| PRIMARY | Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-infinity]) of Anagrelide (SPD422) in Plasma | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12 hours on Day 1 and Day 8, 24 hours on Day 8 | PK set included all participants who received at least 1 dose of investigational product (anagrelide or omeprazole) and had at least 1 measurable post dose plasma concentration. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure. | h*ng/mL | MEAN |
| PRIMARY | Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-infinity]) of 3-Hydroxy (OH)-Anagrelide (Active Metabolite of Anagrelide) in Plasma | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12 hours on Day 1 and Day 8, 24 hours on Day 8 | PK set included all participants who received at least 1 dose of investigational product (anagrelide or omeprazole) and had at least 1 measurable post dose plasma concentration. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure. | h*ng/mL | MEAN |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | From start of study drug administration up to follow-up (up to Day 18) | Safety set included all participants who had taken at least 1 dose of investigational product (anagrelide or omeprazole) and had at least 1 post dose safety assessment. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Anagrelide (SPD422) | SPD422 (Day 1) | 5.028 | Standard Deviation 3.0357 | nanogram per milliliter (ng/mL) | |
| Maximum Observed Plasma Concentration (Cmax) of Anagrelide (SPD422) | SPD422 + Omeprazole (Day 8) | 3.180 | Standard Deviation 1.6707 | nanogram per milliliter (ng/mL) | |
| Maximum Observed Plasma Concentration (Cmax) of 3-Hydroxy (OH)-Anagrelide (Active Metabolite of Anagrelide) | SPD422 (Day 1) | 10.30 | Standard Deviation 3.9633 | ng/mL | |
| Maximum Observed Plasma Concentration (Cmax) of 3-Hydroxy (OH)-Anagrelide (Active Metabolite of Anagrelide) | SPD422 + Omeprazole (Day 8) | 8.341 | Standard Deviation 2.7448 | ng/mL | |
| Area Under the Concentration Versus Time Curve From Zero to Last Time Point (AUC[0-t]) of Anagrelide (SPD422) in Plasma | SPD422 (Day 1) | 13.25 | Standard Deviation 5.9297 | hour*nanogram per milliliter (h*ng/mL) | |
| Area Under the Concentration Versus Time Curve From Zero to Last Time Point (AUC[0-t]) of Anagrelide (SPD422) in Plasma | SPD422 + Omeprazole (Day 8) | 9.683 | Standard Deviation 4.6171 | hour*nanogram per milliliter (h*ng/mL) | |
| Area Under the Concentration Versus Time Curve From Zero to Last Time Point (AUC[0-t]) of 3-Hydroxy (OH)-Anagrelide (Active Metabolite of Anagrelide) in Plasma | SPD422 (Day 1) | 39.51 | Standard Deviation 14.946 | h*ng/mL | |
| Area Under the Concentration Versus Time Curve From Zero to Last Time Point (AUC[0-t]) of 3-Hydroxy (OH)-Anagrelide (Active Metabolite of Anagrelide) in Plasma | SPD422 + Omeprazole (Day 8) | 33.14 | Standard Deviation 10.816 | h*ng/mL | |
| Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-infinity]) of Anagrelide (SPD422) in Plasma | SPD422 (Day 1) | 13.54 | Standard Deviation 5.9951 | h*ng/mL | |
| Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-infinity]) of Anagrelide (SPD422) in Plasma | SPD422 + Omeprazole (Day 8) | 10.27 | Standard Deviation 4.6070 | h*ng/mL |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SPD422 + Omeprazole | 20 | |
| Overall Study | COMPLETED | SPD422 + Omeprazole | 20 | |
| Overall Study | NOT COMPLETED | SPD422 + Omeprazole | 0 |
Source ClinicalTrials.gov
Adverse events4
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 | Nausea | Gastrointestinal disorders | SPD422 + Omeprazole | 4 | 20 | 4 |
| other | Vomiting | Gastrointestinal disorders | SPD422 + Omeprazole | 2 | 20 | 2 |
| other | Headache | Nervous system disorders | SPD422 + Omeprazole | 7 | 20 | 11 |
| other | Insomnia | Psychiatric disorders | SPD422 + Omeprazole | 1 | 20 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SPD422 + Omeprazole | 0 | 20 |
| Total, other adverse events | SPD422 + Omeprazole | 9 | 20 |
| Total, serious adverse events | SPD422 + Omeprazole | 0 | 20 |
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/NCT03866434
GET https://conductscience.org/api/trials/v1/NCT03866434/registered