A STUDY TO EVALUATE THE EFFECT OF PF-06651600 ON PHARMACOKINETICS OF SINGLE DOSE SUMATRIPTAN IN HEALTHY PARTICIPANTS.

Study Overview
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Brief Summary
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Study to evaluate the effect of pf-06651600 on pharmacokinetics of single dose sumatriptan.

Official Title
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A PHASE 1, FIXED-SEQUENCE, OPEN LABEL STUDY TO EVALUATE THE EFFECT OF PF-06651600 ON PHARMACOKINETICS OF SINGLE DOSE SUMATRIPTAN IN HEALTHY PARTICIPANTS

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Sumatriptan
* Drug: PF-06651600


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sumatriptan and PF-06651600 DDI<br>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. | Drug: Sumatriptan<br>* 25 milligrams (mg) single dose tablet<br>Drug: PF-06651600<br>* PF-06651600 400 mg single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sumatriptan area under the curve (AUC) extrapolated to infinite time. |  | Predose, at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post sumatriptan dose. | 
| Sumatriptan (Cmax) maximum plasma concentration |  | Predose, at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post sumatriptan dose. | 
| Sumatriptan AUC last PK sample. |  | Predose, at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post sumatriptan dose. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with significant changes from baseline in vital signs. |  | Baseline through Period 3 Day 4 (Day 8). | 
| Number of participants with significant changes from baseline in electrocardiogram (ECG). |  | Baseline through Period 3 Day 4 (Day 8). | 
| Number of participants with significant changes from baseline in lab tests. |  | Baseline through Period 3 Day 4 (Day 8). | 
| Number of participants with adverse events. |  | Baseline through to Day 28. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PF-06651600, Sumatriptan, Drug-drug interaction study, Pharmacokinetics