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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-08-31

Brief Summary

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Study to evaluate the pharmacokinetic and Mass Balance of single dose \[14C\] AZD9291 in healthy male volunteers

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Detailed Description

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A Single-centre, Non-Randomised, Open-label, Pharmacokinetic and Mass Balance Study of Orally Administered \[14C\]-AZD9291 in Healthy Male Volunteers

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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[14C]-AZD9291 20mg (oral solution)

Volunteers will receive 20 mg \[14C\]-AZD9291 containing a nominal 1 μCi activity, administered by mouth, as a solution.

Group Type EXPERIMENTAL

AZD9291

Intervention Type DRUG

Volunteer will receive a single oral dose of 20 mg \[14C\]-AZD9291 as a solution on Day 1

Interventions

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AZD9291

Volunteer will receive a single oral dose of 20 mg \[14C\]-AZD9291 as a solution on Day 1

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1, Volunteers must be willing to use reliable methods of contraception (condom and spermicide), even if their partners are postmenopausal, surgically sterile, or using an effective hormonal method of contraception or intrauterine coil. 2. In addition, volunteers must agree to continue to take similar contraceptive precautions until 6 months after the last administration of AZD9291 and avoid procreative sex as well as sperm donation for 6 months.

Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes