Study to Investigate Relative Bioavailability of up to Five Different Formulations of AZD5069

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Uncontrolled and Persistent Asthma

Treatments: Drug: Phase IIb formulation; Drug: Test treatment E; Drug: Slow dissolution variant 2; Drug: Putative phase III formulation; Drug: Slow dissolution variant 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT01989520

D3551C00002

Details and patient eligibility

About

Study to investigate relative bioavailability of up to five different formulations of AZD5069

Full description

An Open-label, Single Centre Relative Bioavailability Study With an Adaptive Design Comparing up to 5 Solid Oral AZD5069 Formulations After Single Dose Administration to Healthy Volunteers

Enrollment: 36 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male and/or female volunteers aged 18 to 50 years (inclusive).

2. Non-smokers or ex-smokers with no smoking history for the last 3 months prior to screening.

3. Body mass index (BMI) ≥18.0 and ≤30.0 kg/m2 calculated from height and weight at screening; minimum (min) weight 50 kg and maximum (max) weight 100 kg.

4. Healthy volunteers with neutrophil counts within the laboratory range at screening.

Exclusion criteria

1. A definite or suspected personal history of severe allergy, intolerance or hypersensitivity or ongoing allergy to drugs with a similar chemical structure or class to AZD5069 and/or the excipients, as judged to be clinically relevant by the Investigator.
2. Healthy volunteers who have previously received AZD5069.
3. Volunteers with latent tuberculosis as suggested by their history and judged by the Investigator; confirmatory testing with eg, Quantiferon(R) -TB Gold may be done if required.
4. Volunteers who have received live or live-attenuated vaccine in the 2 weeks prior to the first administration of the IP -

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 5 patient groups

Treatment A

Experimental group

Description:

Phase IIb formulation

Treatment:

Drug: Phase IIb formulation

Treatment B

Experimental group

Description:

Putative phase III formulation

Treatment:

Drug: Putative phase III formulation

Treatment C

Experimental group

Description:

Slow dissolution variant 1

Treatment:

Drug: Slow dissolution variant 1

Treatment D

Experimental group

Description:

Slow dissolution variant 2

Treatment:

Drug: Slow dissolution variant 2

Treatment E

Experimental group

Description:

Optional treatment that may use one of 3 45 mg (intermediate dissolution variant) of AZD5069

Treatment:

Drug: Test treatment E