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NCT05763459 Clinical Trial

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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05763459
Other study ID # M24-192
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date March 24, 2023
Est. completion date June 2, 2023

Study information
Verified date June 2023
Source Calico Life Sciences LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date June 2, 2023
Est. primary completion date May 8, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• ABBV-CLS-7262
Drug: ABBV-CLS-7262 Drug: Digoxin Drug: Rosuvastatin

Locations
Country Name City State
United States AbbVie Clinical Pharmacology Research Unit (ACPRU) Grayslake Illinois

Sponsors (2)
Lead Sponsor Collaborator
Calico Life Sciences LLC AbbVie

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pharmacokinetics of Rosuvastatin Area under the Curve (AUC) Two Weeks
Primary Pharmacokinetics of Digoxin Area under the Curve (AUC) Two Weeks
Secondary Safety and Tolerability Number of patients with treatment-related adverse events as assessed by CTCAE v4.03 Two Weeks
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