NCT05836506

Brief Summary

The main objective of this study is to assess the relative bioavailability and pharmacokinetics of ABBV-903 in healthy adult participants.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2023

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 18, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2023

Completed
Last Updated

July 17, 2023

Status Verified

July 1, 2023

Enrollment Period

2 months

First QC Date

April 20, 2023

Last Update Submit

July 13, 2023

Conditions

Healthy Volunteer

Keywords

ABBV-903Healthy Volunteer

Outcome Measures

Primary Outcomes (6)

  • Number of Participants with Adverse Events (AEs)

    An 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

    Up to Approximately 44 days

  • Maximum Plasma Concentration (Cmax) of ABBV-903

    Cmax of ABBV-903

    Up to approximately 14 days

  • Time to Cmax (Tmax) of ABBV-903

    Tmax of ABBV-903

    Up to approximately 14 days

  • Terminal Phase Elimination Half-Life (t1/2) of ABBV-903

    Terminal phase elimination half-life of ABBV-903

    Up to approximately 14 days

  • Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of ABBV-903

    AUCt of ABBV-903

    Up to approximately 14 days

  • Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-903

    AUCinf of ABBV-903

    Up to approximately 14 days

Study Arms (4)

Part 1: Sequence A

EXPERIMENTAL

In Period 1 on Day 1, participants will receive ABBV-903 Tablet Form 1 after fasting. In Period 2 on Day 1, participants will receive ABBV-903 Tablet Form 2 after fasting. Lastly, in Period 3 on Day 1, participants will receive ABBV-903 Tablet Form 1 after a high fat meal. Participants will be followed up for 30 days.

Drug: ABBV-903 Tablet Form 1Drug: ABBV-903 Tablet Form 2

Part 1: Sequence B

EXPERIMENTAL

In Period 1 on Day 1, participants will receive ABBV-903 Tablet Form 2 after fasting. In Period 2 on Day 1, participants will receive ABBV-903 Tablet Form 1 after fasting. Lastly, in Period 3 on Day 1, participants will receive ABBV-903 Tablet Form 1 after fasting. Participants will be followed up for 30 days.

Drug: ABBV-903 Tablet Form 1Drug: ABBV-903 Tablet Form 2

Part 2: Sequence A

EXPERIMENTAL

In Period 1 on Day 1, participants will receive ABBV-903 Tablet Form 1 after fasting. In Period 2 on Day 1, participants will receive ABBV-903 Tablet Form 2 after fasting. Lastly, in Period 3 on Day 1, participants will receive ABBV-903 Tablet Form 2 after a high fat meal. Participants will be followed up for 30 days.

Drug: ABBV-903 Tablet Form 1Drug: ABBV-903 Tablet Form 2

Part 2: Sequence B

EXPERIMENTAL

In Period 1 on Day 1, participants will receive ABBV-903 Tablet Form 2 after fasting. In Period 2 on Day 1, participants will receive ABBV-903 Tablet Form 1 after fasting. Lastly, in Period 3 on Day 1, participants will receive ABBV-903 Tablet Form 2 after fasting. Participants will be followed up for 30 days.

Drug: ABBV-903 Tablet Form 1Drug: ABBV-903 Tablet Form 2

Interventions

ABBV-903 Tablet Form 1DRUG

Oral Tablets

Part 1: Sequence APart 1: Sequence BPart 2: Sequence APart 2: Sequence B
ABBV-903 Tablet Form 2DRUG

Oral Tablets

Part 1: Sequence APart 1: Sequence BPart 2: Sequence APart 2: Sequence B

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI is ≥ 18.0 to ≤ 32 kg/m2 after rounding to the tenth.
  • Negative test result for SARS-CoV-2 infection at screening visit 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 ECG.

You may not qualify if:

  • 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.
  • History of diseases aggravated or triggered by ultraviolet radiation and no history of abnormal reaction photosensitivity or photoallergy to sunlight, or artificial source of intense light, especially ultraviolet light.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acpru /Id# 254926

Grayslake, Illinois, 60030, United States

Location

Related Links

Study Officials

  • ABBVIE INC.

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2023

First Posted

May 1, 2023

Study Start

April 18, 2023

Primary Completion

June 20, 2023

Study Completion

June 20, 2023

Last Updated

July 17, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)