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

NCT04355845

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Volunteers
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A STUDY TO EVALUATE THE EFFECT OF PF-06651600 ON PHARMACOKINETICS OF SINGLE DOSE SUMATRIPTAN IN HEALTHY PARTICIPANTS.
Official Title  ICMJE A PHASE 1, FIXED-SEQUENCE, OPEN LABEL STUDY TO EVALUATE THE EFFECT OF PF-06651600 ON PHARMACOKINETICS OF SINGLE DOSE SUMATRIPTAN IN HEALTHY PARTICIPANTS
Brief Summary Study to evaluate the effect of pf-06651600 on pharmacokinetics of single dose sumatriptan.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: Sumatriptan
    25 milligrams (mg) single dose tablet
  • Drug: PF-06651600
    PF-06651600 400 mg single dose
Study Arms  ICMJE Experimental: Sumatriptan and PF-06651600 DDI
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.
Interventions:
  • Drug: Sumatriptan
  • Drug: PF-06651600
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 20, 2020)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 13, 2020
Estimated Primary Completion Date July 13, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04355845
Other Study ID Numbers  ICMJE B7981025
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP