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

NCT06009237 | Terminated Phase 1 FDA Drug

• 1 other identifier: M24-227
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

ABBV-903; Healthy Volunteers

Outcome Measures

Primary Outcomes (7)

• Maximum observed plasma concentration (Cmax) of ABBV-903

  Cmax of ABBV-903 will be assessed.

  Up to Day 4

• Time to Cmax (Tmax) of ABBV-903

  Tmax of ABBV-903 will be assessed.

  Up to Day 4

• Apparent Terminal Phase Elimination Rate Constant (β) of ABBV-903

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

  Up to Day 4

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

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

  Up to Day 4

• Area under the Plasma Concentration-time Curve (AUC) from Time 0 to the Time t (AUC0-t) of ABBV-903

  AUC0-t of ABBV-903 will be assessed.

  Up to Day 4

• AUC from Time 0 to Infinity (AUC0-inf) of ABBV-903

  AUC0-inf of ABBV-903 will be assessed.

  Up to Day 4

• Number of Participants with Adverse Events (AEs)

  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.

  Baseline to Day 34

Study Arms (5)

Part 1: Han-Chinese Participants ABBV-903

EXPERIMENTAL

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

Drug: ABBV-903

Part 1: Japanese Participants ABBV-903

EXPERIMENTAL

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

Drug: ABBV-903

Part 1: Placebo

EXPERIMENTAL

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

Drug: Placebo for ABBV-903

Part 2: Japanese Participants ABBV-903

EXPERIMENTAL

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

Drug: ABBV-903

Part 2: Japanese Participants Placebo

EXPERIMENTAL

Japanese participants will receive placebo daily for 10 days.

Drug: Placebo for ABBV-903

Interventions

ABBV-903 DRUG

Tablet; oral

Part 1: Han-Chinese Participants ABBV-903; Part 1: Japanese Participants ABBV-903; Part 2: Japanese Participants ABBV-903

Placebo for ABBV-903 DRUG

Tablet; oral

Part 1: Placebo; Part 2: Japanese Participants Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

Anaheim Clinical Trials LLC /ID# 257033

Anaheim, California, 92801-2658, United States

Location

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: August 24, 2023
• Study Start: August 23, 2023
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)