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Sumatriptan

Phase 1

Healthy Volunteers | Small molecule | Other |Pfizer, Inc.|Last Updated: Sep 3, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment10

FDA Designations

No designations recorded

Clinical trial landscape

Sumatriptan · 1 trial · 1 indication

Phase 1 1
NCT04355845A STUDY TO EVALUATE THE EFFECT OF PF-06651600 ON PHARMACOKINETICS OF SINGLE DOSE SUMATRIPTAN IN HEALTHY PARTICIPANTS.Healthy Volunteers
COMPLETED10 Analytics
PHASE1COMPLETED
A STUDY TO EVALUATE THE EFFECT OF PF-06651600 ON PHARMACOKINETICS OF SINGLE DOSE SUMATRIPTAN IN HEALTHY PARTICIPANTS.
Healthy Volunteers
NCT0435584510
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Study Endpoints

Primary Endpoints

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 Endpoints

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).
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Sumatriptan and PF-06651600 DDIEXPERIMENTALIn 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

NameTypeDescription
SumatriptanDRUG25 milligrams (mg) single dose tablet
PF-06651600DRUGPF-06651600 400 mg single dose
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 wei...

Countries:United States
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Frequently asked questions about Sumatriptan

What is Sumatriptan used for?

Sumatriptan is being studied in healthy volunteers to evaluate its pharmacokinetics when given as a single dose. It is an investigational small molecule in Phase 1 clinical development. The drug is not approved for any indication and is being tested in a research setting.

Who makes Sumatriptan?

Sumatriptan is being developed by Pfizer, Inc., a company traded on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical research on this drug in healthy volunteers.

What phase is Sumatriptan in?

Sumatriptan is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in a single completed Phase 1 trial involving healthy participants.

What clinical trials is Sumatriptan in?

Sumatriptan has one completed clinical trial, identified as NCT04355845. This Phase 1 study evaluated the effect of PF-06651600 on the pharmacokinetics of a single dose of Sumatriptan in healthy participants in the United States. The trial enrolled 10 participants.

Is Sumatriptan the same as PF-06651600?

No, Sumatriptan is not the same as PF-06651600. In the clinical trial NCT04355845, PF-06651600 is a separate drug being studied for its effect on the pharmacokinetics of Sumatriptan. Sumatriptan is the drug whose levels are being measured after administration.