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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-24

Study Completion Date

2023-06-02

Brief Summary

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

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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ABBV-CLS-7262

ABBV-CLS-7262 + Digoxin + Rosuvastatin

Group Type EXPERIMENTAL

ABBV-CLS-7262

Intervention Type DRUG

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

Interventions

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ABBV-CLS-7262

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes