Relative Bioavailability of Two Lutikizumab Formulations and Pharmacokinetics, Safety, and Tolerability of Lutikizumab in Chinese Participants
- Conditions
- Healthy Volunteers
- Interventions
- Registration Number
- NCT06067568
- Lead Sponsor
- AbbVie
- Brief Summary
The purpose of this study is to compare the bioavailability of two different formulations of lutikizumab, and to assess adverse events (AEs) and how lutikizumab moves through the body in healthy Chinese participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
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Male and female healthy volunteers aged between 18 and 60 years.
-- Part 2 only: Participant must be first-generation Han Chinese of full Chinese parentage residing outside of China. Participant must maintain a typical Chinese lifestyle, including consuming a typical Chinese diet.
-
BMI <= 18.0 to <= 29.9 kg/m^2 after rounding to the tenths decimal, at screening and upon initial confinement.
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A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and 12-lead electrocardiogram (ECG).
- Use any medications, vitamins, and/or herbal supplements within the 2 week period or 5 half-lives (whichever is longer) prior to study drug administration.
- History of: epilepsy, any clinically significant cardiac, respiratory (except mild asthma), renal, hepatic ,gastrointestinal, hematologic, demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease, glaucoma, psychiatric disease or disorder, or any uncontrolled medical illness.
- Prior exposure to lutikizumab.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1, Dose B Lutikizumab Dose B Participants will receive a single dose of Lutikizumab Dose B. Part 2 Lutikizumab Dose A Han Chinese participants will receive a single dose of Lutikizumab. Part 1, Dose A Lutikizumab Dose A Participants will receive a single dose of Lutikizumab Dose A.
- Primary Outcome Measures
Name Time Method AUC from Time 0 to Infinity (AUC0-inf) of Lutikizumab Up to Day 8 AUC0-inf of lutikizumab will be assessed.
Number of Participants with Adverse Events (AEs) Baseline to Day 71 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.
Terminal Phase Elimination Half-life (t1/2) of Lutikizumab Up to Day 8 Terminal phase elimination half-life (t1/2) of lutikizumab will be assessed.
Time to Cmax (Tmax) of Lutikizumab Up to Day 8 Tmax of lutikizumab will be assessed.
Apparent Terminal Phase Elimination Rate Constant (β) of Lutikizumab Up to Day 8 Apparent terminal phase elimination rate constant (β) of lutikizumab will be assessed.
Maximum Observed Serum Concentration (Cmax) of Lutikizumab Up to Day 8 Cmax of lutikizumab will be assessed.
Area under the Serum Concentration-time Curve (AUC) from Time 0 to the Time of the Last Measurable Concentration (AUC0-t) of Lutikizumab Up to Day 8 AUC0-t of lutikizumab will be assessed.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Altasciences Clinical Los Angeles, Inc /ID# 260986
🇺🇸Cypress, California, United States
Acpru /Id# 259029
🇺🇸Grayslake, Illinois, United States
PPD Clinical Research Unit - Austin /ID# 260141
🇺🇸Austin, Texas, United States