A Phase 1 Study Assessing the Effect of Food on the Pharmacokinetics of ABBV- CLS-7262

Study Overview
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Brief Summary
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This study is a randomized, three period, six sequence, single dose crossover design with ABBV-CLS-7262 in healthy adult subjects.

Detailed Description
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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.

Official Title
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A Phase 1 Study to Evaluate Safety, Tolerability, and Food-Effect Following Administration of ABBV-CLS-7262 in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: ABBV-CLS-7262


Participation Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Period 1, 2 and 3 ABBV-CLS-7262<br>Participants will receive ABBV-CLS-7262 administered under fasted conditions. Participants will receive ABBV-CLS-7262 administered under fed conditions (high-fat/high-calorie breakfast). Participants will receive ABBV-CLS-7262 administered with applesauce. | Drug: ABBV-CLS-7262<br>* ABBV-CLS-7262<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the pharmacokinetics following a single oral dose of ABBV-CLS-7262 taken with or without food. | Maximum Plasma Concentration [Cmax]; Area under the Curve (AUC) | Approximately Two Weeks | 
| To assess the pharmacokinetics following a single oral dose of ABBV-CLS-7262 administered with or without applesauce. | Maximum Plasma Concentration [Cmax]; Area under the Curve (AUC) | Approximately 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 NCI CTCAE v4.03 | Approximately Six Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Food effect, Pharmacokinetics