Healthy Volunteers
Conditions
Keywords
PF-06651600, Sumatriptan, Drug-drug interaction study, Pharmacokinetics
Brief summary
Study to evaluate the effect of pf-06651600 on pharmacokinetics of single dose sumatriptan.
Interventions
DRUGSumatriptan
25 milligrams (mg) single dose tablet
DRUGPF-06651600
PF-06651600 400 mg single dose
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | 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
| Measure | 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 adverse events. | Baseline through to Day 28. |
| 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). |
Countries
United States
Outcome results
None listed