To Determine the Relative Bioavailability of Different Formulations of AZD9291 and the Effect of Food.

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: AZD9291

Study type: Interventional

Funder types: Industry

Identifiers

NCT01951599

D5160C00005

Details and patient eligibility

About

To determine the relative bioavailability of different oral formulations of AZD9291 and the effect of food in healthy volunteers.

Full description

A Phase I, Open-label, Single-center, Sequential Design Study in Healthy Volunteers to Determine the Relative Bioavailability of Different Oral Formulations of AZD9291 and the Effect of Food

Enrollment: 35 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1, Body mass index between 19 and 30 kg/m2 and weight at least 50 kg and no more than 100 kg. 2, Volunteers must be willing to use a condom, unless their partners are postmenopausal, surgically sterile, or using an effective hormonal method of contraception or intrauterine coil. 3. In addition, volunteers must agree to continue to take similar contraceptive precautions until 4 months after the last dose of AZD9291.

Exclusion criteria

1. Any clinically relevant abnormalities in physical examination, vital signs, hematology, clinical chemistry, urinalysis or ECG at baseline in the opinion of the Investigator.
2. Volunteers who have received live or live-attenuated vaccine in the 2 weeks prior to dosing.
3. History of severe allergy/hypersensitivity or or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to AZD9291, its excipients, or drugs with a similar chemical structure or class.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 5 patient groups

AZD9291 20mg (oral capsule fasted)

Experimental group

Description:

Volunteers will receive AZD9291 20mg administered by mouth, as a capsule, in the fasted state.

Treatment:

Drug: AZD9291

Drug: AZD9291

Drug: AZD9291

Drug: AZD9291

Drug: AZD9291

AZD9291 20mg (oral solution fasted)

Experimental group

Description:

Volunteers will receive AZD9291 20mg administered by mouth, as a solution, in the fasted state.

Treatment:

Drug: AZD9291

Drug: AZD9291

Drug: AZD9291

Drug: AZD9291

Drug: AZD9291

AZD9291 20mg (oral tablet fasted)

Experimental group

Description:

Volunteers will receive AZD9291 20mg administered by mouth, as a tablet, in the fasted state.

Treatment:

Drug: AZD9291

Drug: AZD9291

Drug: AZD9291

Drug: AZD9291

Drug: AZD9291

AZD9291 20mg (oral fasted)

Experimental group

Description:

Volunteers will receive AZD9291 20mg administered by mouth, as a capsule or tablet in the fasted state.

Treatment:

Drug: AZD9291

Drug: AZD9291

Drug: AZD9291

Drug: AZD9291

Drug: AZD9291

AZD9291 20mg (oral fed)

Experimental group

Description:

Volunteers will receive AZD9291 20mg administered by mouth, as a capsule or tablet in the fed state.

Treatment:

Drug: AZD9291

Drug: AZD9291

Drug: AZD9291

Drug: AZD9291

Drug: AZD9291