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

June 28, 2024 updated by: Atrogi AB

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Uppsala, Sweden
        • Clinical Trial Consultants AB

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Participants receive a single dose of ATR-28 in the order Oral capsule - Oral solution with a washout period in between.
Drug: ATR-258 Oral solution
Oral solution
Drug: ATR-258 Oral capsule
Oral capsule
Experimental: Arm 2
Participants receive a single dose of ATR-28 in the order Oral solution - Oral capsule with a washout period in between.
Drug: ATR-258 Oral solution
Oral solution
Drug: ATR-258 Oral capsule
Oral capsule

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atrogi AB

Investigators

  • Study Chair: Erik Waara, Atrogi AB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2024

Primary Completion (Actual)

May 27, 2024

Study Completion (Actual)

May 27, 2024

Study Registration Dates

First Submitted

May 7, 2024

First Submitted That Met QC Criteria

May 22, 2024

First Posted (Actual)

May 29, 2024

Study Record Updates

Last Update Posted (Actual)

July 1, 2024

Last Update Submitted That Met QC Criteria

June 28, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • ATR-258-trial-2
  • 2023-508797-28-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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