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Completed

NCT Number: NCT06432673

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

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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Key information

Conditions

Type2diabetes

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Trial Consultants AB

Uppsala, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ATR-258 Oral solution

Drug

Oral solution

ATR-258 Oral capsule

Drug

Oral capsule

Primary outcomes

  1. Area under the plasma concentration versus time curve (AUC)

    Time frame: 48 hours

  2. Peak Plasma Concentration (Cmax)

    Time frame: 48 hours

Secondary outcomes

  1. Time to maximum plasma concentration (Tmax)

    Time frame: 48 hours

    Tmax

  2. Half life in plasma (T1/2)

    Time frame: 48 hours

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

    Time frame: 48 hours

  4. Volume of distribution following extravascular administration (Vz/F)

    Time frame: 48 hours

  5. Adverse events

    Time frame: 7 days post last dose

    Frequency, intensity and seriousness of reported adverse events

Sponsors and collaborators

Lead sponsor

Atrogi AB

Industry

Registry information

Official study title

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

Acronym: Attractive 2

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 29, 2024
Registry last updated
Jul 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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