The Attractive 2 Trial - Pharmacokinetics of ATR-258 Oral... | NCT06432673

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

NCT06432673

Sponsor

Atrogi AB

Status

Completed

Last Update Posted

Jul 1, 2024Actual

Enrollment

21Actual

Phase

Phase 1

Conditions

Type2diabetes

Interventions

ATR-258 Oral solution
ATR-258 Oral capsule

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2023-508797-28-00	EU Trial (CTIS) Number

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 24, 2024Actual

Primary Completion Date

May 27, 2024Actual

Completion Date

May 27, 2024Actual

First Submitted Date

May 7, 2024

First Submission Date that Met QC Criteria

May 22, 2024

First Posted Date

May 29, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 28, 2024

Last Update Posted Date

Jul 1, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

21Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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 solution Drug: 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 solution Drug: ATR-258 Oral capsule

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ATR-258 Oral solution	Drug	Oral solution	Arm 1 Arm 2

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Time to maximum plasma concentration (Tmax)	Tmax	48 hours
Half life in plasma (T1/2)		48 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Erik Waara	Atrogi AB	Study Chair

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided