Healthy
Conditions
Keywords
Digoxin, Rosuvastatin, Molecular Mechanisms of Pharmacological Action, Physiological effects of drugs
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.
Interventions
DRUGABBV-CLS-7262
Drug: ABBV-CLS-7262 Drug: Digoxin Drug: Rosuvastatin
Sponsors
AbbVie
Calico Life Sciences LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics of Digoxin | Two Weeks | Area under the Curve (AUC) |
| Pharmacokinetics of Rosuvastatin | Two Weeks | Area under the Curve (AUC) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability | Two Weeks | Number of patients with treatment-related adverse events as assessed by CTCAE v4.03 |
Countries
United States
Outcome results
None listed