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A Study to Assess the Relative Bioavailability of Three Immediate-Release Tablet Formulations of ABBV-903 in Healthy Adult Volunteers

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AbbVie

Status and phase

Withdrawn
Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: ABBV-903

Study type

Interventional

Funder types

Industry

Identifiers

NCT06078202
M24-231

Details and patient eligibility

About

The purpose of this study is to evaluate the relative bioavailability of three immediate-release table formulations of ABBV-903 under fasting conditions in healthy volunteers, and to evaluate the effect of food on the pharmacokinetics of three immediate-release table formulations of ABBV-903.

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Body Mass Index (BMI) is >= 18.0 to <= 32.0 kg/m2 after rounding to the tenths decimal, at screening and upon initial confinement.
  • A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).

Exclusion criteria

  • History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.
  • History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), endocrine, renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

0 participants in 5 patient groups

Part 1, Sequence A
Experimental group
Description:
Participants will receive 1 dose of ABBV-903.
Treatment:
Drug: ABBV-903
Part 1, Sequence B
Experimental group
Description:
Participants will receive 1 dose of ABBV-903.
Treatment:
Drug: ABBV-903
Part 1, Sequence C
Experimental group
Description:
Participants will receive 1 dose of ABBV-903.
Treatment:
Drug: ABBV-903
Part 2, Sequence A
Experimental group
Description:
Participants will receive 1 dose of ABBV-903.
Treatment:
Drug: ABBV-903
Part 2, Sequence B
Experimental group
Description:
Participants will receive 1 dose of ABBV-903.
Treatment:
Drug: ABBV-903

Trial contacts and locations

1

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Central trial contact

ABBVIE CALL CENTER

Data sourced from clinicaltrials.gov

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