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

The Attractive 2 Trial - An Open-label, Randomised, 2-period Cross-over Trial to Assess the Pharmacokinetics of ATR-258 Oral Capsule vs. Oral Solution Formulations in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06432673

Acronym

Attractive 2

Enrollment

Registered

2024-05-29

Start date

2024-04-24

Completion date

2024-05-27

Last updated

2024-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type2diabetes

Brief summary

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.

Interventions

DRUGATR-258 Oral solution

Oral solution

DRUGATR-258 Oral capsule

Oral capsule

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Area under the plasma concentration versus time curve (AUC)	48 hours
Peak Plasma Concentration (Cmax)	48 hours

Secondary

Measure	Time frame	Description
Apparent total body clearance following extravascular administration (CL/F)	48 hours	—
Time to maximum plasma concentration (Tmax)	48 hours	Tmax
Adverse events	7 days post last dose	Frequency, intensity and seriousness of reported adverse events
Volume of distribution following extravascular administration (Vz/F)	48 hours	—
Half life in plasma (T1/2)	48 hours	—

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026