Determine Central 5-HT1B Receptor Occupancy of ZOMIG® Rapimelt (Zolmitriptan) in Healthy Male Volunteers

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Migraine

Treatments: Drug: [11C]AZ10419369; Drug: Rapimelt

Study type: Interventional

Funder types: Industry

Identifiers

NCT01085123

D1220C00005

Details and patient eligibility

About

The purpose of this study is to determine the central 5-HT1B receptor occupancy of ZOMIG® Rapimelt (zolmitriptan) in healthy male volunteers.

Enrollment: 10 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body mass index between ≥19 and ≤30 kg/m2.

Exclusion criteria

• A history or presence of neurological, haematological, psychiatric, gastrointestinal, hepatic, pulmonary, renal disease
• Use of drugs that induce the liver drug metabolising enzymes within 4 weeks before first PET

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

1

Experimental group

Description:

PET 1: baseline, PET 2: 10 mg Zomig® Rapimelt, PET 3: 5 mg ZOMIG® Rapimelt, PET 4 2.5 mg ZOMIG® Rapimelt

Treatment:

Drug: Rapimelt

Drug: [11C]AZ10419369