The Attractive 2 Trial - Pharmacokinetics of ATR-258 Oral Capsule vs. Oral Solution Formulations in Healthy Volunteers

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

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-24

Study Completion Date

2024-05-27

Brief Summary

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This is a single-centre, open-label, randomised, 2-period cross-over, Phase 1 comparative trial to assess the ATR-258 pharmacokinetic (PK) parameters of an oral capsule formulation in comparison with an oral solution formulation, both given as single doses to healthy volunteers. The order of treatment, i.e., the treatment sequence capsule - solution or solution - capsule, will be randomised.

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Detailed Description

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Conditions

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Type2diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1

Participants receive a single dose of ATR-28 in the order Oral capsule - Oral solution with a washout period in between.

Group Type EXPERIMENTAL

ATR-258 Oral solution

Intervention Type DRUG

Oral solution

ATR-258 Oral capsule

Intervention Type DRUG

Oral capsule

Arm 2

Participants receive a single dose of ATR-28 in the order Oral solution - Oral capsule with a washout period in between.

Group Type EXPERIMENTAL

ATR-258 Oral solution

Intervention Type DRUG

Oral solution

ATR-258 Oral capsule

Intervention Type DRUG

Oral capsule

Interventions

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ATR-258 Oral solution

Oral solution

Intervention Type DRUG

ATR-258 Oral capsule

Oral capsule

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Provision of informed consent
* Body mass index ≥ 18.5 and ≤ 30.0
* Medically healthy participant
* Willing to use of double barrier contraceptive method if of childbearing potential

Exclusion Criteria

* History or clinical manifestation of any clinically significant disease
* History of dysphagia or any other swallowing disorder
* Current smokers or users of nicotine products
* History or manifestation of drug abuse, alcohol abuse and/or excessive intake of alcohol

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes