A Study to Assess the Safety, Tolerability, and Interactions of ABBV-CLS-616 Oral Tablets in Healthy Adult Participants
Phase 1
Recruiting
- Conditions
- Interventions
- Registration Number
- NCT06698926
- Lead Sponsor
- AbbVie
- Brief Summary
This is a Phase 1, first in human, randomized, four-part study to investigate the safety, tolerability, and pharmacokinetics of ABBV-CLS-616 after oral dosing in healthy volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 112
Inclusion Criteria
- Part 2 only: Participant must have normal platelet count at screening and upon initial confinement.
- Part 2 only: Participant must not have known or suspected coagulopathy, or prothrombin time (PT)/activated partial thromboplastin time (aPTT)/international normalized ratio (INR) values outside of normal range at screening.
- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, neurological examination, ophthalmic examination (Part 2 only) laboratory profile and a 12-lead Electrocardiogram.
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Exclusion Criteria
- Part 2 only: Clinically significant active or recurrent ocular disease.
- History of lumbar puncture and/or collection of cerebrospinal fluid within 30 days prior to Screening.
- History of current condition of chronic lower back pain.
- Evidence of conditions that might preclude the subject from undergoing a lumbar puncture.
- History: of clinically significant neurological epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, coagulopathy, or any uncontrolled medical illness.
- History of suicidal ideation within one year prior to study drug administration as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia Suicide Severity Rating Scale completed at Screening, or any history of suicide attempts within the last two years.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1: Group 2 ABBV-CLS-616 Participants will receive either ABBV-CLS-616 Dose B or placebo after fasting on Day 1 and will be confined for 19 days. Part 1: Group 2 Placebo Participants will receive either ABBV-CLS-616 Dose B or placebo after fasting on Day 1 and will be confined for 19 days. Part 1: Group 1 ABBV-CLS-616 Participants will receive either ABBV-CLS-616 Dose A or placebo after fasting on Day 1 and will be confined for 19 days. Part 1: Group 1 Placebo Participants will receive either ABBV-CLS-616 Dose A or placebo after fasting on Day 1 and will be confined for 19 days. Part 1: Group 3 ABBV-CLS-616 Participants will receive either ABBV-CLS-616 Dose C or placebo after fasting on Day 1 and will be confined for 19 days. Part 1: Group 3 Placebo Participants will receive either ABBV-CLS-616 Dose C or placebo after fasting on Day 1 and will be confined for 19 days. Part 1: Group 4 ABBV-CLS-616 Participants will receive either ABBV-CLS-616 Dose D or placebo after fasting on Day 1 and will be confined for 19 days. Part 1: Group 4 Placebo Participants will receive either ABBV-CLS-616 Dose D or placebo after fasting on Day 1 and will be confined for 19 days. Part 1: Group 5 ABBV-CLS-616 Participants will receive either ABBV-CLS-616 Dose E or placebo after fasting on Day 1 and will be confined for 19 days. Part 1: Group 5 Placebo Participants will receive either ABBV-CLS-616 Dose E or placebo after fasting on Day 1 and will be confined for 19 days. Part 1: Group 6 ABBV-CLS-616 Participants will receive either ABBV-CLS-616 Dose F or placebo after fasting on Day 1 and will be confined for 19 days. Part 1: Group 6 Placebo Participants will receive either ABBV-CLS-616 Dose F or placebo after fasting on Day 1 and will be confined for 19 days. Part 2: Group 7 ABBV-CLS-616 Participants will receive either ABBV-CLS-616 Dose G or placebo daily, starting on Day 1, for 14 days while confined for 26 days. Part 2: Group 7 Placebo Participants will receive either ABBV-CLS-616 Dose G or placebo daily, starting on Day 1, for 14 days while confined for 26 days. Part 2: Group 8 ABBV-CLS-616 Participants will receive either ABBV-CLS-616 Dose H or placebo daily, starting on Day 1, for 14 days while confined for 26 days. Part 2: Group 8 Placebo Participants will receive either ABBV-CLS-616 Dose H or placebo daily, starting on Day 1, for 14 days while confined for 26 days. Part 2: Group 9 ABBV-CLS-616 Participants will receive either ABBV-CLS-616 Dose D or placebo daily, starting on Day 1, for 14 days while confined for 26 days. Part 2: Group 9 Placebo Participants will receive either ABBV-CLS-616 Dose D or placebo daily, starting on Day 1, for 14 days while confined for 26 days. Part 2: Group 10 ABBV-CLS-616 Participants will receive either ABBV-CLS-616 Dose E or placebo daily, starting on Day 1, for 14 days while confined for 26 days. Part 2: Group 10 Placebo Participants will receive either ABBV-CLS-616 Dose E or placebo daily, starting on Day 1, for 14 days while confined for 26 days. Part 2: Group 11 ABBV-CLS-616 Participants will receive either ABBV-CLS-616 Dose F or placebo daily, starting on Day 1, for 14 days while confined for 26 days. Part 2: Group 11 Placebo Participants will receive either ABBV-CLS-616 Dose F or placebo daily, starting on Day 1, for 14 days while confined for 26 days. Part 3: Sequence 1 ABBV-CLS-616 In Period 1, participants will be confined for 19 days and receive ABBV-CLS-616 Dose C on Day 1 after fasting. In Period 2, Participants will be confined for 19 days and receive ABBV-CLS-616 Dose C on Day 1, without fasting. Part 3: Sequence 2 ABBV-CLS-616 In Period 1, Participants will be confined for 19 days and receive ABBV-CLS-616 Dose C on Day 1, without fasting. In Period 2, participants will be confined for 19 days and receive ABBV-CLS-616 Dose C on Day 1 after fasting. Part 4: Itraconazole ABBV-CLS-616 In Period 1, Participants will be confined for 19 days and receive ABBV-CLS-616 Dose C on Day 1, without fasting. In Period 2, participants will be confined for 22 days and receive ABBV-CLS-616 Dose C on Day 4 without fasting. Participants will also receive Itraconazole daily for 21 days. Part 4: Itraconazole Itraconazole In Period 1, Participants will be confined for 19 days and receive ABBV-CLS-616 Dose C on Day 1, without fasting. In Period 2, participants will be confined for 22 days and receive ABBV-CLS-616 Dose C on Day 4 without fasting. Participants will also receive Itraconazole daily for 21 days.
- Primary Outcome Measures
Name Time Method Number of Participants with Adverse Events (AEs) Up to approximately 90 days An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Acpru /Id# 270532
🇺🇸Grayslake, Illinois, United States