A STUDY TO EVALUATE THE EFFECT OF PF-06651600 ON PHARMACOKINETICS OF SINGLE DOSE SUMATRIPTAN IN HEALTHY PARTICIPANTS.
NCT04355845
ABOUT THIS STUDY
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- Male and/or female participants who are healthy as determined by medical evaluation including medical history, full physical examination which includes BP and pulse rate measurements, clinical laboratory tests, and 12-lead ECG.
- BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological,
dermatological, or allergic disease (including drug allergies, but excluding
untreated, asymptomatic, seasonal allergies at the time of dosing), diabetes or of the
contraindications as per the USPI for IMITREX.
- 10-year risk of atherosclerotic cardiovascular disease (based on ASCVD Risk Estimator)
≥7.5%.
- Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
- Systemic therapy with any of the medications that are MAO-A inhibitors within 14 days
or 5 half-lives (whichever is longer) prior to the first dose of investigational
product. Concomitant use of any ergotamine-containing or ergot-type medication (like
dihydroergotamine or methysergide), or other 5-HT agonist (Section 6.5) within 14 days
or 5 half-lives (whichever is longer) prior to the first dose of investigational
product.
- Known participation in a clinical trial of PF-06651600 within 60 days prior to the
first dose of investigational product; participation in any clinical trial of
PF-06651600 and the participant experienced AE that led to discontinuation or had an
SAE that in the judgment of the investigator were PF-06651600-related.
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Descriptive Information | |||||
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Brief Title ICMJE | A STUDY TO EVALUATE THE EFFECT OF PF-06651600 ON PHARMACOKINETICS OF SINGLE DOSE SUMATRIPTAN IN HEALTHY PARTICIPANTS. | ||||
Official Title ICMJE | A PHASE 1, FIXED-SEQUENCE, OPEN LABEL STUDY TO EVALUATE THE EFFECT OF PF-06651600 ON PHARMACOKINETICS OF SINGLE DOSE SUMATRIPTAN IN HEALTHY PARTICIPANTS | ||||
Brief Summary | Study to evaluate the effect of pf-06651600 on pharmacokinetics of single dose sumatriptan. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Sequential Assignment Masking: None (Open Label) Primary Purpose: Basic Science | ||||
Condition ICMJE | Healthy Volunteers | ||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Sumatriptan and PF-06651600 DDI
In Period 1, participants will receive a single oral 25 mg dose of sumatriptan on Day 1 in the morning. In Period 2 on Day 1, participants will receive a single oral 25 mg dose of sumatriptan and a single 400 mg oral dose of PF-06651600 in the morning. In Period 3 participants will receive a single 400 mg oral dose of PF-06651600 in the evening of Day 1, and then a single oral 25 mg dose of sumatriptan in the morning of Day 2. Interventions:
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE | 10 | ||||
Original Estimated Enrollment ICMJE | 12 | ||||
Actual Study Completion Date ICMJE | August 10, 2020 | ||||
Actual Primary Completion Date | August 10, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 55 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04355845 | ||||
Other Study ID Numbers ICMJE | B7981025 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||
Verification Date | September 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |