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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: ABBV-CLS-7262

• Registration Number: NCT05763459
• Lead Sponsor: Calico Life Sciences LLC

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-02-27
• Study First Submitted QC: 2023-03-08
• Study First Posted: 2023-03-10
• Study Start: 2023-03-24
• Primary Completion: 2023-05-08
• Status Verified: 2023-06
• Study Completion: 2023-06-02
• Last Update Submitted: 2023-06-23
• Last Update Posted: 2023-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ABBV-CLS-7262	ABBV-CLS-7262	ABBV-CLS-7262 + Digoxin + Rosuvastatin

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics of Rosuvastatin	Two Weeks	Area under the Curve (AUC)
Pharmacokinetics of Digoxin	Two Weeks	Area under the Curve (AUC)

Secondary Outcome Measures

Name	Time	Method
Safety and Tolerability	Two Weeks	Number of patients with treatment-related adverse events as assessed by CTCAE v4.03

Trial Locations

Locations (1)

AbbVie Clinical Pharmacology Research Unit (ACPRU); 🇺🇸 Grayslake, Illinois, United States