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

Calico Life Sciences

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: ABBV-CLS-7262

Study type

Interventional

Funder types

Industry

Identifiers

NCT05763459

M24-192

Details and patient eligibility

About

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

Full 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.

Enrollment

12 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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