Phase I, Exploratory, Single Centre, Single Oral Dose AZD9668 and Intravenous Microdose of [C14] AZD9668, Healthy Subject

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: AZD9668

• Registration Number: NCT01161355
• Lead Sponsor: AstraZeneca

Brief Summary

The primary objective of this study is to assess the absolute bioavailability and to evaluate pharmacokinetic parameters of a single oral dose and a radiolabelled intravenous microdose of \[14C\]AZD9668 in healthy male subjects.

Detailed Description

This is an exploratory study to assess the absolute bioavailability of a single oral dose of AZD9668 with respect to an intra-venous microdose of \[14C\]AZD9668 in healthy male subjects.

Study Timeline

• Study Start: 2010-06
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Study First Submitted: 2010-06-18
• Study First Submitted QC: 2010-07-12
• Study First Posted: 2010-07-13
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-08
• Last Update Posted: 2011-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

Inclusion Criteria

• Provision of signed and dated, written informed consent prior to any study specific procedures
• Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weight at least 50 kg and no more than 100 kg.

Exclusion Criteria

• Any clinically significant disease or disorder
• Any clinically significant abnormalities at screening examination

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AZD9668	AZD9668	Tablets and intravenous (IV) dose

Primary Outcome Measures

Name	Time	Method
The absolute bioavailability and evaluation of pharmacokinetic parameters (AUC, AUC (0-t), Cmax, t½, tmax, and MRT of of a single oral dose and a radiolabelled intravenous microdose of [14C]AZD9668	Multiple Pharmacokinetic blood samples for up to 96 hours following drug administration

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability of AZD9668: Adverse events, clinical chemistry, haematology, urinalysis, vital signs, electrocardiogram, physical examination	measured within 21 days of drug administration and up to 7 days following drug administration

Trial Locations

Locations (1)

Research Site; 🇬🇧 London, United Kingdom