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

Atrogi AB21 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Type2diabetes

Interventions

ATR-258 Oral solutionDRUG

Oral solution

ATR-258 Oral capsuleDRUG

Oral capsule

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Clinical Trial Consultants AB

Uppsala, Sweden

Outcomes

Primary Outcomes

Area under the plasma concentration versus time curve (AUC)

Time frame: 48 hours

Peak Plasma Concentration (Cmax)

Time frame: 48 hours

Secondary Outcomes

Time to maximum plasma concentration (Tmax)

Tmax

Time frame: 48 hours

Half life in plasma (T1/2)

Time frame: 48 hours

Apparent total body clearance following extravascular administration (CL/F)

Time frame: 48 hours

Volume of distribution following extravascular administration (Vz/F)

Time frame: 48 hours

Adverse events

Frequency, intensity and seriousness of reported adverse events

Time frame: 7 days post last dose

Data from ClinicalTrials.gov

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