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

June 23, 2023 updated by: Calico Life Sciences LLC

A Phase 1 Study to Evaluate the Drug-Drug Interaction Between ABBV-CLS-7262, Rosuvastatin, and Digoxin Following Multiple Doses of ABBV-CLS-7262

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Grayslake, Illinois, United States, 60030
        • AbbVie Clinical Pharmacology Research Unit (ACPRU)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics of Rosuvastatin
Time Frame: Two Weeks
Area under the Curve (AUC)
Two Weeks
Pharmacokinetics of Digoxin
Time Frame: Two Weeks
Area under the Curve (AUC)
Two Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Tolerability
Time Frame: Two Weeks
Number of patients with treatment-related adverse events as assessed by CTCAE v4.03
Two Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Calico Life Sciences LLC

Collaborators

AbbVie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2023

Primary Completion (Actual)

May 8, 2023

Study Completion (Actual)

June 2, 2023

Study Registration Dates

First Submitted

February 27, 2023

First Submitted That Met QC Criteria

March 8, 2023

First Posted (Actual)

March 10, 2023

Study Record Updates

Last Update Posted (Actual)

June 26, 2023

Last Update Submitted That Met QC Criteria

June 23, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • M24-192

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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