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

AstraZeneca6 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

AZD9668DRUG

Tablets of AZD9668 and IV dose of \[C14\]AZD9668

Eligibility

Sex: MALEMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Research Site

Ruddington, Nottingham, United Kingdom

Research Site

London, United Kingdom

Outcomes

Primary Outcomes

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

Time frame: Multiple Pharmacokinetic blood samples for up to 96 hours following drug administration

Secondary Outcomes

Safety and tolerability of AZD9668: Adverse events, clinical chemistry, haematology, urinalysis, vital signs, electrocardiogram, physical examination

Time frame: measured within 21 days of drug administration and up to 7 days following drug administration

Data from ClinicalTrials.gov

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