Open Label, Healthy Volunteers, ADME Study With Single Oral Administration of [14C] AZD5069

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2011-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a phase I, open label, healthy volunteers, ADME study with single oral administration of \[14C\] AZD5069.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Healthy Volunteers, Absorption, Distribution, Metabolism and Excretion (ADME) Study With Single Oral Administration of [14C] AZD8931

NCT01284595

Healthy

COMPLETED PHASE1

Single Oral Dose of 60 mg [14C]AZD9668 in Healthy Male Volunteers

NCT01147549

Healthy

COMPLETED PHASE1

To Study the Absorption, Distribution, Metabolism and Excretion of AZD1305

NCT00689247

Healthy

COMPLETED PHASE1

Phase I Study to Assess Absorption, Metabolism & Excretion of a Single Oral Dose [14C]AZD0530 in Healthy Male Volunteers

NCT00853983

Healthy

COMPLETED PHASE1

Study Evaluating the Pharmacokinetic and Mass Balance of Single Dose [14C] AZD9291 in Volunteers

NCT02096679

Healthy Volunteers

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

\[14C\] AZD5069

Group Type EXPERIMENTAL

[14C] AZD5069

Intervention Type DRUG

Single 120 mg oral dose administered on Day 1

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

[14C] AZD5069

Single 120 mg oral dose administered on Day 1

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Have a body mass index (BMI) of ≥18 and ≤30 kg/m2 and weight of ≥50 kg and ≤100 kg.
* Regular daily bowel movements (ie, production of at least 1 stool per day).
* Non-smoker or ex-smoker who has not used tobacco or nicotine products for ≥6 months prior to Visit 1
* Healthy Male volunteers aged 50 and over

Exclusion Criteria

* Healthy volunteers who have been exposed to radiation levels above background (eg, through X-ray examination) of \>5 mSv in the last year, \>10 mSv in the last 5 years, or a cumulative total of \>1 mSv per year of life
* Participation in any prior radiolabelled study within last 5 years
* History of alcohol abuse or excessive intake of alcohol as judged by the investigator.

Minimum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes