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Completed

NCT Number: NCT06145607

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

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

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

AbbVie Clinical Pharmacology Research Unit (ACPRU)

Grayslake, Illinois, 60030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ABBV-CLS-7262

Drug

ABBV-CLS-7262

Primary outcomes

  1. To assess the pharmacokinetics following a single oral dose of ABBV-CLS-7262 taken with or without food.

    Time frame: Approximately Two Weeks

    Maximum Plasma Concentration [Cmax]; Area under the Curve (AUC)

  2. To assess the pharmacokinetics following a single oral dose of ABBV-CLS-7262 administered with or without applesauce.

    Time frame: Approximately Two Weeks

    Maximum Plasma Concentration [Cmax]; Area under the Curve (AUC)

Secondary outcomes

  1. Safety and Tolerability

    Time frame: Approximately Six Weeks

    Number of patients with treatment-related adverse events as assessed by NCI CTCAE v4.03

Sponsors and collaborators

Lead sponsor

Calico Life Sciences LLC

Industry

Collaborators

  • AbbVie

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 24, 2023
Registry last updated
Mar 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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