Multiple Ascending Dose Study for AZD 7268 in Japanese Healthy Male Volunteers (JMAD)

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: AZD7268

Study type: Interventional

Funder types: Industry

Identifiers

NCT01116011

D1151C00004

Details and patient eligibility

About

This is a multiple ascending dose study (MAD) in the Japanese population with AZD7268. This MAD study will evaluate the safety, tolerability and pharmacokinetics of orally administered AZD7268 after multiple ascending doses.

Enrollment: 30 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Provision of Informed Consent
• Healthy male subjects, with suitable veins for cannulation or repeated venipuncture

Exclusion criteria

• Inability to understand or cooperate with given information
• Any positive result on screening for human immune deficiency virus (HIV), Hepatitis B, Hepatitis C and syphilis test
• History of seizure (including infant febrile seizures) or family history of seizure

Trial design

30 participants in 2 patient groups, including a placebo group

AZD7268

Experimental group

Treatment:

Drug: AZD7268

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo