Healthy
Conditions
Keywords
Food effect, Pharmacokinetics
Brief summary
This study is a randomized, three period, six sequence, single dose crossover design with ABBV-CLS-7262 in healthy adult subjects.
Detailed description
On Day 1 of each period, subjects will receive a single oral dose of ABBV-CLS-7262 administered according to the food regimen assigned. There will be a 4-day washout period between doses. Food regimens include administration after fasting, following a high-fat/high-calorie meal, or with apple sauce. Upon completion each subject will have taken a total of three doses of ABBV-CLS-7262, with one dose administered with each food regimen.
Interventions
DRUGABBV-CLS-7262
ABBV-CLS-7262
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 55 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 55 years of age inclusive at the time of screening. * Body Mass Index (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 |
|---|---|---|
| To assess the pharmacokinetics following a single oral dose of ABBV-CLS-7262 taken with or without food. | Approximately Two Weeks | Maximum Plasma Concentration \[Cmax\]; Area under the Curve (AUC) |
| To assess the pharmacokinetics following a single oral dose of ABBV-CLS-7262 administered with or without applesauce. | Approximately Two Weeks | Maximum Plasma Concentration \[Cmax\]; Area under the Curve (AUC) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability | Approximately Six Weeks | Number of patients with treatment-related adverse events as assessed by NCI CTCAE v4.03 |
Countries
United States
Outcome results
None listed