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

AstraZeneca30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Interventions

AZD7268DRUG

Capsule, Oral, BID

PlaceboDRUG

Capsule, Oral, BID

Eligibility

Sex: MALEMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Kanagawa, Sagamihara, Japan

Outcomes

Primary Outcomes

Investigate the safety and tolerability of AZD7268 by Adverse Events.

Time frame: From first dosing throughout the treatment period and including the follow-up period

Secondary Outcomes

Characterize the PK parameters(Cmax, AUC,t1/2) of AZD7268 by assessment of drug concentrations in plasma

Time frame: Blood samples will be taken from pre-dose until 48 hours post last dose

Characterize the PK parameters (CLr, Ae) of AZD7268 by assessment of drug concentrations in urine

Time frame: Urine samples will be taken from post first dose until 48 hours post last dose.

Data from ClinicalTrials.gov

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