## Protocol Section
### Identification Module
**NCT ID:** NCT06432673

**Acronym:** Attractive 2

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

**Official 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

#### Organization Study ID Info
**ID:** ATR-258-trial-2
#### Organization
**Class:** INDUSTRY
**Full Name:** Atrogi AB
#### Secondary ID Infos
**ID:** 2023-508797-28-00
**Type:** CTIS
### Status Module
#### Completion Date
**Date:** 2024-06

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-06

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-24

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-07
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Atrogi AB

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### 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.

### Conditions Module

**Conditions:**

- Type2diabetes

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 21

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants receive a single dose of ATR-28 in the order Oral capsule - Oral solution with a washout period in between.

**Intervention Names:**

- Drug: ATR-258 Oral solution

- Drug: ATR-258 Oral capsule

**Label:** Arm 1

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants receive a single dose of ATR-28 in the order Oral solution - Oral capsule with a washout period in between.

**Intervention Names:**

- Drug: ATR-258 Oral solution

- Drug: ATR-258 Oral capsule

**Label:** Arm 2

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Arm 1

- Arm 2

**Description:** Oral solution

**Name:** ATR-258 Oral solution

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Arm 1

- Arm 2

**Description:** Oral capsule

**Name:** ATR-258 Oral capsule

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Area under the plasma concentration versus time curve (AUC)

**Time Frame:** 48 hours

**Measure:** Peak Plasma Concentration (Cmax)

**Time Frame:** 48 hours

#### Secondary Outcomes

**Description:** Tmax

**Measure:** Time to maximum plasma concentration (Tmax)

**Time Frame:** 48 hours

**Measure:** Half life in plasma (T1/2)

**Time Frame:** 48 hours

**Measure:** Apparent total body clearance following extravascular administration (CL/F)

**Time Frame:** 48 hours

**Measure:** Volume of distribution following extravascular administration (Vz/F)

**Time Frame:** 48 hours

**Description:** Frequency, intensity and seriousness of reported adverse events

**Measure:** Adverse events

**Time Frame:** 7 days post last dose

### 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

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** torbjorn.strom@pharmarelations.se

**Name:** Torbjörn Ström

**Phone:** +468590 745 80

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Uppsala

**Contacts:**

***Contact 1:***

- **Email:** rfp@ctc-ab.se

- **Name:** Måns Jergil

- **Phone:** +46 18 30 33 00

- **Role:** CONTACT

**Country:** Sweden

**Facility:** Clinical Trial Consultants AB

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** Atrogi AB

**Name:** Erik Waara

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: LOW

- As Found: Unknown

- ID: M7119

- Name: Diabetes Mellitus, Type 2

- Relevance: LOW

- As Found: Unknown

- ID: T4202

- Name: Oculocerebral Syndrome With Hypopigmentation

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
