Study to Evaluate the Effect of Erenumab on Blood Pressure When Given Concomitantly With Subcutaneous Sumatriptan

Amgen

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Placebo; Drug: Sumatriptan; Drug: Erenumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02741310

2015-004537-28 (EudraCT Number)

20140255

Details and patient eligibility

About

The primary objective of this study was to assess the effects of subcutaneous sumatriptan alone and the effects of a single dose of erenumab (AMG 334) intravenous (IV) and sumatriptan concomitant therapy on resting blood pressure in healthy adults.

Enrollment: 34 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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 liver disease
• Positive Hepatitis B or Hepatitis C
• Unwilling or unable to limit alcohol consumption
• Unable to refrain from strenuous exercise
• Other Exclusion Criteria May Apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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34 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants 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).

Treatment:

Drug: Placebo

Drug: Sumatriptan

Erenumab

Experimental group

Description:

Participants 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).

Treatment:

Drug: Erenumab

Drug: Placebo

Drug: Sumatriptan