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

Atrogi

Status and phase: Completed; Phase 1

Conditions: Type2diabetes

Treatments: Drug: ATR-258 Oral solution; Drug: ATR-258 Oral capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT06432673

ATR-258-trial-2

2023-508797-28-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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21 participants in 2 patient groups

Arm 1

Experimental group

Description:

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

Treatment:

Drug: ATR-258 Oral capsule

Drug: ATR-258 Oral solution

Arm 2

Experimental group

Description:

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

Treatment:

Drug: ATR-258 Oral capsule

Drug: ATR-258 Oral solution