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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT06009237
• Other study ID #: M24-227
• Status: Terminated
• Phase: Phase 1
• Start date: August 23, 2023
• Est. completion date: October 30, 2023

Study information

• Verified date: November 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: October 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• ABBV-903
Tablet; oral
• Placebo for ABBV-903
Tablet; oral

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials LLC /ID# 257033	Anaheim	California

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (Cmax) of ABBV-903	Cmax of ABBV-903 will be assessed.	Up to Day 4
Primary	Time to Cmax (Tmax) of ABBV-903	Tmax of ABBV-903 will be assessed.	Up to Day 4
Primary	Apparent Terminal Phase Elimination Rate Constant (ß) of ABBV-903	Apparent terminal phase elimination rate constant (ß) of ABBV-903 will be assessed.	Up to Day 4
Primary	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
Primary	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
Primary	AUC from Time 0 to Infinity (AUC0-inf) of ABBV-903	AUC0-inf of ABBV-903 will be assessed.	Up to Day 4
Primary	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