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A Study to Assess Pharmacokinetics, Safety, and Tolerability of ABBV-903 in Healthy Japanese and Han Chinese Participants

Sponsor
AbbVie (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06009237
Collaborator
(none)
42
Enrollment
5
Arms
3.4
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The objective of this study is to assess the pharmacokinetics (PK), safety, and tolerability of ABBV-903 or placebo in healthy adult Japanese and Han Chinese subjects.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
42 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
A Study to Evaluate Pharmacokinetics, Safety, and Tolerability of ABBV-903 in Healthy Japanese and Han Chinese Subjects
Anticipated Study Start Date :
Aug 21, 2023
Anticipated Primary Completion Date :
Dec 3, 2023
Anticipated Study Completion Date :
Dec 3, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part 1: Han-Chinese Participants ABBV-903

Han-Chinese participants will receive a single dose of ABBV-903.

Drug: ABBV-903
Tablet; oral
Experimental: Part 1: Japanese Participants ABBV-903

Japanese participants will receive a single dose of ABBV-903.

Drug: ABBV-903
Tablet; oral
Experimental: Part 1: Placebo

Participants will receive a single dose of Placebo for ABBV-903.

Drug: Placebo for ABBV-903
Tablet; oral
Experimental: Part 2: Japanese Participants ABBV-903

Japanese participants will receive ABBV-903 daily for 10 days.

Drug: ABBV-903
Tablet; oral
Experimental: Part 2: Japanese Participants Placebo

Japanese participants will receive placebo daily for 10 days.

Drug: Placebo for ABBV-903
Tablet; oral

Outcome Measures

Primary Outcome Measures

  1. Maximum observed plasma concentration (Cmax) of ABBV-903 [Up to Day 4]

    Cmax of ABBV-903 will be assessed.

  2. Time to Cmax (Tmax) of ABBV-903 [Up to Day 4]

    Tmax of ABBV-903 will be assessed.

  3. Apparent Terminal Phase Elimination Rate Constant (β) of ABBV-903 [Up to Day 4]

    Apparent terminal phase elimination rate constant (β) of ABBV-903 will be assessed.

  4. Terminal Phase Elimination Half-life (t1/2) of ABBV-903 [Up to Day 4]

    Terminal phase elimination half-life (t1/2) of ABBV-903 will be assessed.

  5. Area under the Plasma Concentration-time Curve (AUC) from Time 0 to the Time t (AUC0-t) of ABBV-903 [Up to Day 4]

    AUC0-t of ABBV-903 will be assessed.

  6. AUC from Time 0 to Infinity (AUC0-inf) of ABBV-903 [Up to Day 4]

    AUC0-inf of ABBV-903 will be assessed.

  7. Number of Participants with Adverse Events (AEs) [Baseline to Day 34]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Healthy Japanese or Han Chinese male or female; age is between 18 and 65 years, inclusive at the time of screening.

  • Han Chinese subject must be first-generation Han Chinese of full Chinese parentage residing outside of China. Subjects must maintain a typical Chinese lifestyle, including consuming a typical Chinese diet.

OR

  • Japanese subject must be first- or second generation Japanese of full Japanese parentage. First-generation subjects will have been born in Japan to two parents and four grandparents also born in Japan of full Japanese descent. Second-generation subjects born outside of Japan must have two parents and four grandparents born in Japan of full Japanese descent. All subjects must maintain a typical Japanese lifestyle, including consuming a typical Japanese diet.

  • Body Mass Index (BMI) is >= 18.0 to <= 30.0 kg/m2 after rounding to the tenths decimal, at screening and upon initial confinement. BMI is calculated as weight in kg divided by the square of height measured in meters.

Exclusion Criteria:

  • History of any clinically significant illness/infection/major febrile illness, hospitalization, as determined by the investigator, or any surgical procedure within 30 days prior to the first dose of study drug.

  • Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma orlocalized carcinoma in situ of the cervix.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
AbbVie
ClinicalTrials.gov Identifier:
NCT06009237
Other Study ID Numbers:
  • M24-227
First Posted:
Aug 24, 2023
Last Update Posted:
Aug 24, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by AbbVie
ABBV-903
Healthy Volunteers

Study Results

No Results Posted as of Aug 24, 2023