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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04355845
• Other study ID #: B7981025
• Status: Completed
• Phase: Phase 1
• Start date: June 15, 2020
• Est. completion date: August 10, 2020

Study information

• Verified date: September 2020
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 10, 2020
• Est. primary completion date: August 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Sumatriptan
25 milligrams (mg) single dose tablet
• PF-06651600
PF-06651600 400 mg single dose

Locations

Country	Name	City	State
United States	New Haven Clinical Research Unit	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	Number of participants with significant changes from baseline in vital signs.		Baseline through Period 3 Day 4 (Day 8).
Secondary	Number of participants with significant changes from baseline in electrocardiogram (ECG).		Baseline through Period 3 Day 4 (Day 8).
Secondary	Number of participants with significant changes from baseline in lab tests.		Baseline through Period 3 Day 4 (Day 8).
Secondary	Number of participants with adverse events.		Baseline through to Day 28.

External Links

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