## Protocol Section
### Identification Module
**NCT ID:** NCT06425003

**Brief Title:** Study of [14C] ABBV-CLS-7262 in Healthy Male Volunteers Following Single Oral Dose Administration

**Official Title:** Mass Balance Study of [14C] ABBV-CLS-7262 in Healthy Male Volunteers Following Single Oral Dose Administration

#### Organization Study ID Info
**ID:** M24-326
#### Organization
**Class:** INDUSTRY
**Full Name:** Calico Life Sciences LLC
### Status Module
#### Completion Date
**Date:** 2024-07-11

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-24

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-07-11

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-06
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** AbbVie

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Calico Life Sciences LLC

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

### Description Module

**Brief Summary:** The purpose of this study is to evaluate mass balance, pharmacokinetics and safety of \[14C\] ABBV-CLS-7262 in healthy, male volunteers following administration of a single oral dose.

### Conditions Module

**Conditions:**

- Healthy Volunteer

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 7

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants will receive \[14C\] ABBV-CLS-7262 on Day 1.

**Intervention Names:**

- Drug: [14C] ABBV-CLS-7262

**Label:** [14C] ABBV-CLS-7262

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- [14C] ABBV-CLS-7262

**Description:** Oral Solution

**Name:** [14C] ABBV-CLS-7262

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

**Measure:** Number of Participants with Adverse Events (AEs)

**Time Frame:** Up to approximately 30 days from last dose.

**Description:** Cmax will be assessed.

**Measure:** Maximum observed concentration (Cmax)

**Time Frame:** Up to approximately Day 15 from last dose

**Description:** Tmax will be assessed.

**Measure:** Time to Cmax (peak time, Tmax)

**Time Frame:** Up to approximately 15 days from last dose

**Description:** Terminal phase elimination half-life (t1/2) will be assessed.

**Measure:** Terminal phase elimination half-life (t1/2)

**Time Frame:** Up to approximately 15 days from last dose

**Description:** AUCt will be assessed.

**Measure:** Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable concentration (AUCt)

**Time Frame:** Up to approximately 15 days from last dose

**Description:** Percentage total radioactivity

**Measure:** Percent radioactivity excreted

**Time Frame:** Up to approximately 15 days from last dose

**Description:** Identification of the major metabolites

**Measure:** Identification of metabolites excreted

**Time Frame:** Up to approximately 15 days from last dose

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.
* Body Max Index (BMI) is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenths decimal at screening.

Exclusion Criteria:

* Considering fathering a child or donating sperm during the study and for 94 days after study drug administration, or is unwilling to comply with protocol recommended contraception recommendations.
* History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.
* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), endocrine, metabolic, renal, hepatic, gastrointestinal, hematologic, endocrinologic or psychiatric disease or disorder, or any uncontrolled medical illness.
* Has had significant exposure to radiation for professional or medical reasons (e.g., serial x-rays or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring), except dental x-rays, within 12 months prior to study drug administration.

**Healthy Volunteers:** True

**Maximum Age:** 55 Years

**Minimum Age:** 18 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** abbvieclinicaltrials@abbvie.com

**Name:** AbbVie Call Center

**Phone:** +1 (844) 663-3742

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Madison

**Country:** United States

**Facility:** Fortrea Clinical Research Unit Inc.

**State:** Wisconsin

**Status:** RECRUITING

**Zip:** 53704

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### 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
