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Completed

NCT Number: NCT04355845

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

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

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sumatriptan

Drug

25 milligrams (mg) single dose tablet

PF-06651600

Drug

PF-06651600 400 mg single dose

Primary outcomes

  1. Sumatriptan area under the curve (AUC) extrapolated to infinite time.

    Time frame: Predose, at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post sumatriptan dose.

  2. Sumatriptan (Cmax) maximum plasma concentration

    Time frame: Predose, at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post sumatriptan dose.

  3. Sumatriptan AUC last PK sample.

    Time frame: Predose, at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post sumatriptan dose.

Secondary outcomes

  1. Number of participants with significant changes from baseline in vital signs.

    Time frame: Baseline through Period 3 Day 4 (Day 8).

  2. Number of participants with significant changes from baseline in electrocardiogram (ECG).

    Time frame: Baseline through Period 3 Day 4 (Day 8).

  3. Number of participants with significant changes from baseline in lab tests.

    Time frame: Baseline through Period 3 Day 4 (Day 8).

  4. Number of participants with adverse events.

    Time frame: Baseline through to Day 28.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 21, 2020
Registry last updated
Sep 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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