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

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

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.

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

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: ABBV-CLS-7262


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABBV-CLS-7262<br>ABBV-CLS-7262 + Digoxin + Rosuvastatin | Drug: ABBV-CLS-7262<br>* Drug: ABBV-CLS-7262 Drug: Digoxin Drug: Rosuvastatin<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Digoxin, Rosuvastatin, Molecular Mechanisms of Pharmacological Action, Physiological effects of drugs