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

NCT04355845 | Completed Phase 1 FDA Drug

• 1 other identifier: B7981025
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Keywords

PF-06651600; Sumatriptan; Drug-drug interaction study; Pharmacokinetics

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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.

Study Arms (1)

Sumatriptan and PF-06651600 DDI

EXPERIMENTAL

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; Drug: PF-06651600

Interventions

Sumatriptan DRUG

25 milligrams (mg) single dose tablet

Sumatriptan and PF-06651600 DDI

PF-06651600 DRUG

PF-06651600 400 mg single dose

Sumatriptan and PF-06651600 DDI

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Sumatriptan; PF-06651600

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2020
• First Posted: April 21, 2020
• Study Start: June 15, 2020
• Primary Completion: August 10, 2020
• Study Completion: August 10, 2020
• Last Updated: September 3, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)