A Study in Healthy Volunteers to Assess Safety and Blood Levels of AZD5847 After Multiple Doses Over 14 Days

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: AZD5847; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01116258

D3430C00002

Details and patient eligibility

About

The purpose of this study is to determine the safety, tolerability and blood levels of AZD5847 after daily oral dosing for 14 days.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• BMI between 18-30

Exclusion criteria

• Use of drugs that inhibit or induce cytochrome P450 3A4 enzymes
• History of presence of gastrointestinal, hepatic or renal disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: AZD5847

2

Placebo Comparator group

Treatment:

Drug: Placebo