A Phase 1 Study of ABBV-CLS-7262, Rosuvastatin, and Digoxin in Healthy Subjects

• Sponsor: Calico Life Sciences LLC (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05763459
• Collaborator: AbbVie (Industry)
• Enrollment: 12
• Arm: 1
• Anticipated Duration (Months): 6

Study Details

Study Description

Brief Summary

This study follows an open-label, single arm design with two periods with rosuvastatin, digoxin and ABBV-CLS-7262

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: ABBV-CLS-7262	Phase 1

Detailed Description

Period 1: One single dose of rosuvastatin and one single dose of digoxin on Day 1.

Period 2: Multiple doses of ABBV-CLS-7262 once daily from Day 1 to Day 8. On Day 5, one single dose of rosuvastatin and one single dose of digoxin with the dose of ABBV-CLS-7262 on that day.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1 Study to Evaluate the Drug-Drug Interaction Between ABBV-CLS-7262, Rosuvastatin, and Digoxin Following Multiple Doses of ABBV-CLS-7262
• Anticipated Study Start Date: Mar 1, 2023
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ABBV-CLS-7262 ABBV-CLS-7262 + Digoxin + Rosuvastatin	Drug: ABBV-CLS-7262; Drug: ABBV-CLS-7262 Drug: Digoxin Drug: Rosuvastatin

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetics of Rosuvastatin [Two Weeks]

   Area under the Curve (AUC)

2. Pharmacokinetics of Digoxin [Two Weeks]

   Area under the Curve (AUC)

Secondary Outcome Measures

1. Safety and Tolerability [Two Weeks]

   Number of patients with treatment-related adverse events as assessed by CTCAE v4.03

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Adult volunteers in general good health

• Must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures

• Individuals between 18 and 65 years of age inclusive at the time of screening

• BMI is ≥ 18.0 to ≤ 32.0 kg/m2

• All male subjects who are sexually active and not surgically sterilized must agree to use an acceptable contraceptive method. Additionally, male subjects must agree to not donate sperm during the study until 30 days after the final dose of study drug

• All female subjects who are sexually active and of childbearing potential must agree to use a highly effective contraceptive method. Additionally, female subjects must agree to not donate eggs during the study and for 30 days after the final dose of study drug.

Exclusion Criteria:

• Subject who, in the opinion of the investigator, is incapable of completing study-required visits and procedures

• Pregnant or breastfeeding.

• Treatment with any other investigational treatment within 30 days

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Calico Life Sciences LLC
• AbbVie

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Calico Life Sciences LLC
• ClinicalTrials.gov Identifier: NCT05763459
• Other Study ID Numbers: M24-192
• First Posted: Mar 10, 2023
• Last Update Posted: Mar 10, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Calico Life Sciences LLC: Digoxin; Rosuvastatin; Molecular Mechanisms of Pharmacological Action; Physiological effects of drugs

Study Results

No Results Posted as of Mar 10, 2023