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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Sumatriptan; Drug: PF-06651600

• Registration Number: NCT04355845
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-06
• Study First Submitted QC: 2020-04-20
• Study First Posted: 2020-04-21
• Study Start: 2020-06-15
• Primary Completion: 2020-08-10
• Study Completion: 2020-08-10
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-01
• Last Update Posted: 2020-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Sumatriptan and PF-06651600 DDI	PF-06651600	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.
Sumatriptan and PF-06651600 DDI	Sumatriptan	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

New Haven Clinical Research Unit; 🇺🇸 New Haven, Connecticut, United States