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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-04-30

Brief Summary

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

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Detailed Description

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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

Conditions

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Uncontrolled and Persistent Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Treatment A

Phase IIb formulation

Group Type EXPERIMENTAL

Phase IIb formulation

Intervention Type DRUG

Single oral dose 45mg AZD5069

Treatment B

Putative phase III formulation

Group Type EXPERIMENTAL

Putative phase III formulation

Intervention Type DRUG

Single oral dose 45mg AZD5069

Treatment C

Slow dissolution variant 1

Group Type EXPERIMENTAL

Slow dissolution variant 1

Intervention Type DRUG

Single oral dose 45mg AZD5069

Treatment D

Slow dissolution variant 2

Group Type EXPERIMENTAL

Slow dissolution variant 2

Intervention Type DRUG

Single oral dose 45mg AZD 5069

Treatment E

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

Group Type EXPERIMENTAL

Test treatment E

Intervention Type DRUG

Tablet formulation E, 45 mg (intermediate dissolution variant) of AZD5069

Interventions

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Phase IIb formulation

Single oral dose 45mg AZD5069

Intervention Type DRUG

Putative phase III formulation

Single oral dose 45mg AZD5069

Intervention Type DRUG

Slow dissolution variant 1

Single oral dose 45mg AZD5069

Intervention Type DRUG

Slow dissolution variant 2

Single oral dose 45mg AZD 5069

Intervention Type DRUG

Test treatment E

Tablet formulation E, 45 mg (intermediate dissolution variant) of AZD5069

Intervention Type DRUG

Eligibility Criteria

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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.

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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 -

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes