A Study in Healthy Volunteers to Assess the Tolerability and Blood Levels of a Single Dose of AZD7687

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: AZD7687; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01046357

D2710C00001

Details and patient eligibility

About

This is a Phase I, first time in human, randomised, blinded, placebo-controlled, single ascending dose study in healthy male volunteers conducted at a single centre. The effect of food on the pharmacokinetics of AZD7687 will also be studied.

The study will consist of two parts, a dose escalation part and a food interaction part. The two parts will be run in parallel. In total, 64 healthy volunteers divided in 8 different panels (8 volunteers per cohort) will be exposed to single doses during the dose escalation. Each subject will receive dose only once, except for the volunteers included in the dose steps repeated for food interaction.

Enrollment: 64 estimated patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy
• BMI between 19-30

Exclusion criteria

• No blood donation prior 30 days
• No other clinical study prior 3 months

Trial design

64 participants in 2 patient groups

Active

Experimental group

Description:

AZD7687 oral suspension

Treatment:

Drug: AZD7687

Placebo

Experimental group

Description:

placebo oral suspension

Treatment:

Drug: Placebo