NCT06432673

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2024

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 24, 2024

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2024

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 29, 2024

Completed
Last Updated

July 1, 2024

Status Verified

May 1, 2024

Enrollment Period

1 month

First QC Date

May 7, 2024

Last Update Submit

June 28, 2024

Conditions

Type2diabetes

Outcome Measures

Primary Outcomes (2)

  • Area under the plasma concentration versus time curve (AUC)

    48 hours

  • Peak Plasma Concentration (Cmax)

    48 hours

Secondary Outcomes (5)

  • Time to maximum plasma concentration (Tmax)

    48 hours

  • Half life in plasma (T1/2)

    48 hours

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

    48 hours

  • Volume of distribution following extravascular administration (Vz/F)

    48 hours

  • Adverse events

    7 days post last dose

Study Arms (2)

Arm 1

EXPERIMENTAL

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 solutionDrug: ATR-258 Oral capsule

Arm 2

EXPERIMENTAL

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 solutionDrug: ATR-258 Oral capsule

Interventions

ATR-258 Oral solutionDRUG

Oral solution

Arm 1Arm 2
ATR-258 Oral capsuleDRUG

Oral capsule

Arm 1Arm 2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Trial Consultants AB

Uppsala, Sweden

Location

Study Officials

  • Erik Waara

    Atrogi AB

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2024

First Posted

May 29, 2024

Study Start

April 24, 2024

Primary Completion

May 27, 2024

Study Completion

May 27, 2024

Last Updated

July 1, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)