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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05738850
Other study ID # M23-889
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date February 15, 2023
Est. completion date May 31, 2024

Study information

Verified date May 2024
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main objective of this study is to assess pharmacokinetics, safety, and tolerability of ABBV-932 in healthy adult participants.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 104
Est. completion date May 31, 2024
Est. primary completion date May 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Parts 1 and 2: Healthy individuals with body-mass index (BMI) >= 18.0 to <= 32.0 kg/m2, rounded to the tenths decimal. - Part 3: Healthy Japanese, Han Chinese individuals with BMI >= 18.0 to <= 30.0 kg/m2, rounded to the tenths decimal. - Condition of general good health based upon the results of a medical history, physical examination, vital signs, laboratory profile, neurological examination, and a 12-lead ECG. Exclusion Criteria: - History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ABBV-932
Oral Capsule
Placebo
Oral Capsule

Locations

Country Name City State
United States Anaheim Clinical Trials LLC /ID# 254178 Anaheim California
United States Acpru /Id# 249639 Grayslake Illinois

Sponsors (2)

Lead Sponsor Collaborator
AbbVie Gedeon Richter Plc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum Plasma Concentration (Cmax) of ABBV-932 Cmax of ABBV-932. Up to approximately 5 days
Primary Time to Cmax (Tmax) of ABBV-932 Tmax of ABBV-932. Up to approximately 5 days
Primary Terminal Phase Elimination Rate Constant (Beta) of ABBV-932 Terminal phase elimination rate constant (beta) of ABBV-932. Up to approximately 5 days
Primary Terminal Phase Elimination Half-Life (t1/2) of ABBV-932 Terminal phase elimination half-life of ABBV-932. Up to approximately 5 days
Primary Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-932 AUCt of ABBV-932. Up to approximately 5 days
Primary Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-932 AUCinf of ABBV-932. Up to approximately 5 days
Primary Maximum Plasma Concentration (Cmax) of DCAR Cmax of DCAR. Up to approximately 5 days
Primary Time to Cmax (Tmax) of DCAR Tmax of DCAR. Up to approximately 5 days
Primary Terminal Phase Elimination Rate Constant (Beta) of DCAR Terminal phase elimination rate constant (beta) of DCAR. Up to approximately 5 days
Primary Terminal Phase Elimination Half-Life (t1/2) of DCAR Terminal phase elimination half-life of DCAR. Up to approximately 5 days
Primary Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of DCAR AUCt of DCAR. Up to approximately 5 days
Primary Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of DCAR AUCinf of DCAR. Up to approximately 5 days
Primary Maximum Plasma Concentration (Cmax) of DDCAR Cmax of DDCAR. Up to approximately 5 days
Primary Time to Cmax (Tmax) of DDCAR Tmax of DDCAR. Up to approximately 5 days
Primary Terminal Phase Elimination Rate Constant (Beta) of DDCAR Terminal phase elimination rate constant (beta) of DDCAR. Up to approximately 5 days
Primary Terminal Phase Elimination Half-Life (t1/2) of DDCAR Terminal phase elimination half-life of DDCAR. Up to approximately 5 days
Primary Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of DDCAR AUCt of DDCAR. Up to approximately 5 days
Primary Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of DDCAR AUCinf of DDCAR. Up to approximately 5 days
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