A Study to Assess the Safety, Tolerability, and Interactions of ABBV-CLS-616 Oral Tablets in Healthy Adult Participants

AbbVie

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: Itraconazole; Drug: ABBV-CLS-616; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06698926

M25-206

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Exclusion criteria

• Part 2 only: Clinically significant active or recurrent ocular disease.
• Part 2 only: History of lumbar puncture and/or collection of cerebrospinal fluid within 30 days prior to Screening.
• Part 2 only: 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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110 participants in 14 patient groups

Part 1: Group 1

Experimental group

Description:

Participants will receive either ABBV-CLS-616 Dose A or placebo after fasting on Day 1 and will be confined for 19 days.

Treatment:

Drug: Placebo

Drug: ABBV-CLS-616

Part 1: Group 2

Experimental group

Description:

Participants will receive either ABBV-CLS-616 Dose B or placebo after fasting on Day 1 and will be confined for 19 days.

Treatment:

Drug: Placebo

Drug: ABBV-CLS-616

Part 1: Group 3

Experimental group

Description:

Participants will receive either ABBV-CLS-616 Dose C or placebo after fasting on Day 1 and will be confined for 8 days.

Treatment:

Drug: Placebo

Drug: ABBV-CLS-616

Part 1: Group 4

Experimental group

Description:

Participants will receive either ABBV-CLS-616 Dose D or placebo after fasting on Day 1 and will be confined for 8 days.

Treatment:

Drug: Placebo

Drug: ABBV-CLS-616

Part 1: Group 5

Experimental group

Description:

Participants will receive either ABBV-CLS-616 Dose E or placebo after fasting on Day 1 and will be confined for 8 days.

Treatment:

Drug: Placebo

Drug: ABBV-CLS-616

Part 1: Group 6

Experimental group

Description:

Participants will receive either ABBV-CLS-616 Dose F or placebo after fasting on Day 1 and will be confined for 8 days.

Treatment:

Drug: Placebo

Drug: ABBV-CLS-616

Part 2: Group 7

Experimental group

Description:

Participants will receive either ABBV-CLS-616 Dose G or placebo daily, starting on Day 1 for 7 days and will be confined for 14 days.

Treatment:

Drug: Placebo

Drug: ABBV-CLS-616

Part 2: Group 8

Experimental group

Description:

Participants will receive either ABBV-CLS-616 Dose H or placebo daily, starting on Day 1 for 7 days and will be confined for 14 days.

Treatment:

Drug: Placebo

Drug: ABBV-CLS-616

Part 2: Group 9

Experimental group

Description:

Participants will receive either ABBV-CLS-616 Dose D or placebo daily, starting on Day 1 for 7 days and will be confined for 14 days.

Treatment:

Drug: Placebo

Drug: ABBV-CLS-616

Part 2: Group 10

Experimental group

Description:

Participants will receive either ABBV-CLS-616 Dose E or placebo daily, starting on Day 1 for 7 days and will be confined for 14 days.

Treatment:

Drug: Placebo

Drug: ABBV-CLS-616

Part 2: Group 11

Experimental group

Description:

Participants will receive either ABBV-CLS-616 Dose F or placebo daily, starting on Day 1 for 7 days and will be confined for 14 days.

Treatment:

Drug: Placebo

Drug: ABBV-CLS-616

Part 3: Sequence 1

Experimental group

Description:

In Period 1, participants will receive ABBV-CLS-616 Dose C on Day 1 after fasting and will be confined for 7 days. In Period 2, participants will receive ABBV-CLS-616 Dose C on Day 1, without fasting and will be confined for 8 days.

Treatment:

Drug: ABBV-CLS-616

Part 3: Sequence 2

Experimental group

Description:

In Period 1, participants will receive ABBV-CLS-616 Dose C on Day 1 without fasting and will be confined for 7 days. In Period 2, participants will receive ABBV-CLS-616 Dose C on Day 1, after fasting and will be confined for 8 days.

Treatment:

Drug: ABBV-CLS-616

Part 4: Itraconazole

Experimental group

Description:

In Period 1, participants will receive ABBV-CLS-616 Dose C on Day 1, after fasting and will be confined for 7 days. In Period 2, participants will receive Itraconazole daily for 10 days without fasting and will receive ABBV-CLS-616 Dose C on Day 4 after fasting. Participants will be confined for 11 days.

Treatment:

Drug: ABBV-CLS-616

Drug: Itraconazole