A Thorough QT Study of ABBV-CLS-7262 in Healthy Subjects

NCT06310876 | Completed Phase 1 FDA Drug

• 1 other identifier: M24-852
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, blinded, placebo and active-controlled, 4-period, crossover design thorough QT/QTc (TQT) study to evaluate the effect of ABBV-CLS-7262 on cardiac repolarization in healthy adult subjects.

Conditions

Healthy

Keywords

TQT; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• To evaluate the effect of ABBV-CLS-7262 on the QTc interval in healthy adult subjects

  To evaluate the effect of ABBV-CLS-7262 on the QTc interval in healthy adult subjects.

  Up to 24 hours

Secondary Outcomes (3)

• To evaluate the effects of ABBV-CLS-7262 on change in electrocardiogram (ECG) parameters

  Up to 24 hours

• To evaluate the sensitivity of QTc measurement using moxifloxacin

  Up to 24 hours

• To evaluate the effect of ABBV-CLS-7262 on T-wave morphology

  Up to 24 hours

Study Arms (4)

Sequence 1

EXPERIMENTAL

Subjects will receive ABBV-CLS-7262 dose 1, ABBV-CLS-7262 dose 2, placebo, or moxifloxacin 400 mg tablet

Drug: ABBV-CLS-7262; Drug: Placebo; Drug: Moxifloxacin 400mg

Sequence 2

EXPERIMENTAL

Subjects will receive ABBV-CLS-7262 dose 1, ABBV-CLS-7262 dose 2, placebo, or moxifloxacin 400 mg tablet

Drug: ABBV-CLS-7262; Drug: Placebo; Drug: Moxifloxacin 400mg

Sequence 3

EXPERIMENTAL

Subjects will receive ABBV-CLS-7262 dose 1, ABBV-CLS-7262 dose 2, placebo, or moxifloxacin 400 mg tablet

Drug: ABBV-CLS-7262; Drug: Placebo; Drug: Moxifloxacin 400mg

Sequence 4

EXPERIMENTAL

Subjects will receive ABBV-CLS-7262 dose 1, ABBV-CLS-7262 dose 2, placebo, or moxifloxacin 400 mg tablet

Drug: ABBV-CLS-7262; Drug: Placebo; Drug: Moxifloxacin 400mg

Interventions

ABBV-CLS-7262 DRUG

• single oral Dose 1

Sequence 1; Sequence 2; Sequence 3; Sequence 4

Placebo DRUG

• single oral dose

Sequence 1; Sequence 2; Sequence 3; Sequence 4

Moxifloxacin 400mg DRUG

• single oral dose

Sequence 1; Sequence 2; Sequence 3; Sequence 4

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 ≤ 29.9 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Calico Life Sciences LLC: lead
• AbbVie: collaborator

Study Sites (1)

AbbVie Clinical Pharmacology Research Unit (ACPRU)

Grayslake, Illinois, 60030, United States

Location

MeSH Terms

Interventions

Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 15, 2024
• Study Start: March 14, 2024
• Primary Completion: May 29, 2024
• Study Completion: June 26, 2024
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)