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Sumatriptan

Phase 1

Healthy Subjects | Small molecule | Other |Amgen Inc.|Last Updated: Apr 2, 2019

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment34

FDA Designations

No designations recorded

Clinical trial landscape

Sumatriptan · 1 trial · 1 indication

Phase 1 1
NCT02741310Study to Evaluate the Effect of Erenumab on Blood Pressure When Given Concomitantly With Subcutaneous SumatriptanHealthy Subjects
COMPLETED34 Analytics
PHASE1COMPLETED
Study to Evaluate the Effect of Erenumab on Blood Pressure When Given Concomitantly With Subcutaneous Sumatriptan
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Study Endpoints

Primary Endpoints

Time-weighted Averages of Mean Arterial Pressure
Days 2 and 5 from predose to 2.5 hours after sumatriptan dosing.

Mean arterial pressure (MAP) is the average arterial pressure during a single cardiac cycle. MAP was calculated as diastolic blood pressure (DBP) + 0.33 \* (systolic blood pressure \[SBP\]-DBP). Individual time-weighted average in MAP were calculated as area under the measurement-time curve from predose through 2.5 hours of MAP divided by the time period over which the measurements were made (ie, AUCmap0-2.5 hr /2.5 hours). Data were analyzed using a linear mixed effects regression model with fixed effects for treatment and period and random effect for subject; Sumatriptan Alone data include participants from both Groups A (Parts 1 and 2) and B (Part 1 only).

Secondary Endpoints

Number of Participants With Adverse Events
From the first dose of study drug (sumatriptan, placebo or erenumab) until 84 days after the last dose (89 days). Part 1 includes AEs from day 1 to predose on day 4 and Part 2 includes AEs from day 4 through day 89.
Area Under the Concentration-time Curve From Time 0 to 6 Hours for Sumatriptan
Day 2 and day 5 at 1 hour (prior to 2nd sumatriptan injection), 1 hour 10 minutes, 1.25, 1.5, 2, 3, 4.5, and 7 hours relative to the first 6 mg dose of sumatriptan.
Area Under the Concentration-time Curve From Time 0 to Infinity for Sumatriptan
Day 2 and day 5 at 1 hour (prior to 2nd sumatriptan injection), 1 hour 10 minutes, 1.25, 1.5, 2, 3, 4.5, and 7 hours relative to the first 6 mg dose of sumatriptan.
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATORParticipants received a placebo intravenous (IV) infusion on day 1 then 12 mg subcutaneous sumatriptan on day 2 (Part 1). After a 2-day washout participants received another placebo IV infusion on day 4 followed by 12 mg subcutaneous sumatriptan on day 5 (Part 2).
ErenumabEXPERIMENTALParticipants received a placebo intravenous (IV) infusion on day 1 then 12 mg subcutaneous sumatriptan on day 2 (Part 1). After a 2-day washout participants received 140 mg erenumab IV infusion on day 4 followed by 12 mg subcutaneous sumatriptan on day 5 (Part 2).

Interventions

NameTypeDescription
PlaceboDRUGAdministered by intravenous infusion
SumatriptanDRUGAdministered by two 6 mg subcutaneous injections 1 hour apart on day 2 and day 5
ErenumabDRUGAdministered by intravenous infusion
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and female subjects ≥ 18 to ≤ 55 years old * Good general health * Laboratory results within range * Other Inclusion Criteria May Apply Exclusion Criteria: * Female subjects pregnant or breastfeeding * An unstable medical condition * History of cancer * Active l...

Countries:Belgium
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Frequently asked questions about Sumatriptan

What is Sumatriptan used for?

Sumatriptan is a small molecule being studied in healthy subjects. It is being evaluated in a Phase 1 clinical trial to assess its effect on blood pressure when given concomitantly with subcutaneous sumatriptan. The drug is being developed by Amgen Inc. (NASDAQ: AMGN).

Who makes Sumatriptan?

Sumatriptan is being developed by Amgen Inc., which is listed on the NASDAQ under the ticker symbol AMGN. The company is conducting a Phase 1 clinical trial involving the drug.

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 Phase 1 trial is completed and involved 34 healthy subjects.

What clinical trials is Sumatriptan in?

Sumatriptan is associated with one completed Phase 1 clinical trial, NCT02741310, titled 'Study to Evaluate the Effect of Erenumab on Blood Pressure When Given Concomitantly With Subcutaneous Sumatriptan.' The trial was conducted in Belgium with 34 healthy volunteers.

Is Sumatriptan the same as Erenumab?

No, Sumatriptan is not the same as Erenumab. The clinical trial NCT02741310 evaluates the effect of Erenumab on blood pressure when given concomitantly with subcutaneous Sumatriptan, indicating they are separate drugs being studied together.