Skip to main content
OpenTrials
Completed

NCT Number: NCT05763459

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

AbbVie Clinical Pharmacology Research Unit (ACPRU)

Grayslake, Illinois, 60030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ABBV-CLS-7262

Drug

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

Primary outcomes

  1. Pharmacokinetics of Rosuvastatin

    Time frame: Two Weeks

    Area under the Curve (AUC)

  2. Pharmacokinetics of Digoxin

    Time frame: Two Weeks

    Area under the Curve (AUC)

Secondary outcomes

  1. Safety and Tolerability

    Time frame: Two Weeks

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

Sponsors and collaborators

Lead sponsor

Calico Life Sciences LLC

Industry

Collaborators

  • AbbVie

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 10, 2023
Registry last updated
Jun 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.