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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT06009237
Other study ID # M24-227
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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