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Completed

NCT Number: NCT06477926

A Study to Assess Relative Bioavailability and Food Effect of ABBV-668 Extended-Release Formulations in Adult Participants

The objectives of this study are to assess safety and tolerability of the new ABBV-668 ER tablets, to assess the oral bioavailability of the ABBV-668 ER tablets relative to the ABBV-668 IR capsules, and to assess the pharmacokinetics of the ER tablets under fasting and fed conditions in healthy adults.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Acpru /Id# 266960

Grayslake, Illinois, 60030, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • BMI is ≥ 18.0 to ≤ 32.0 kg/m^2 after rounding to the tenths decimal at screening.
  • A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.

Exclusion criteria

  • History of any clinically significant sensitivity or allergy to any medication or food.
  • History of any investigational drug within 30 days or 5 half-lives of the drug (whichever is longer) prior to the first dose of study drug or is currently enrolled in another clinical study or was previously enrolled in this study.
  • History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
  • Participant using any medication, vitamins and/or herbal supplements (including traditional Chinese medicine), with the exception of hormonal replacement therapies for females, on a regular basis.
  • Any use of tobacco or nicotine-containing products within 180 days prior to the first dose of study drug.

Treatment and study plan

ABBV-668 IR

Drug
  • Oral Capsule

ABBV-668 ER

Drug
  • Oral Tablets

Primary outcomes

  1. Maximum Plasma Concentration (Cmax) of ABBV-668

    Time frame: Up to approximately 47 days

    Cmax of ABBV-668

  2. Time to Cmax (Tmax) of ABBV-668

    Time frame: Up to approximately 47 days

    Tmax of ABBV-668

  3. Terminal Phase Elimination Rate Constant (Beta) of ABBV-668

    Time frame: Up to approximately 47 days

    Terminal phase elimination rate constant (beta) of ABBV-668

  4. Terminal Phase Elimination Half-Life (t1/2) of ABBV-668

    Time frame: Up to approximately 47 days

    Terminal phase elimination half-life of ABBV-668

  5. Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-668

    Time frame: Up to approximately 47 days

    AUCt of ABBV-668

  6. Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-688

    Time frame: Up to approximately 47 days

    AUCinf of ABBV-688

  7. Number of Participants With Adverse Events (AEs)

    Time frame: Up to Day 47

    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Phase 1 Relative Bioavailability and Food Effect Study of ABBV-668 Extended-Release Formulations

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 27, 2024
Registry last updated
Oct 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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