A Study to Assess Adverse Events and How Single and Multiple Ascending Doses of ABBV-903 Move Through the Body in Healthy Adults
Phase 1
Completed
- Conditions
- Healthy Volunteer
- Interventions
- Registration Number
- NCT05691699
- Lead Sponsor
- AbbVie
- Brief Summary
The purpose of this study is to evaluate adverse events and tolerability of single and multiple doses of ABBV-903, and to assess how the drug moves through the body in healthy adult volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 104
Inclusion Criteria
- Body Mass Index (BMI) is => 18.0 to <= 32 kg/m2 after rounded to the nearest tenth, at Screening and upon initial confinement.
- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (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.
- History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
- Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in situ of the cervix.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1, ABBV-903 ABBV-903 Participants will receive a single ascending dose of ABBV-903 in Part 1. Part 1, Placebo Placebo for ABBV-903 Participants will receive a single ascending dose of placebo in Part 1. Part 2, ABBV-903 ABBV-903 Participants will receive multiple ascending doses of ABBV-903 in Part 2. Part 2, Placebo Placebo for ABBV-903 Participants will receive multiple ascending doses of placebo in Part 2. Part 3, Sequence 1 ABBV-903 Participants in Part 3 will follow Sequence 1. Part 3, Sequence 2 ABBV-903 Participants in Part 3 will follow Sequence 2. Part 3, Sequence 1 Itraconazole Participants in Part 3 will follow Sequence 1. Part 3, Sequence 2 Itraconazole Participants in Part 3 will follow Sequence 2.
- Primary Outcome Measures
Name Time Method Time to Cmax (Tmax) Baseline to Day 36 Tmax will be assessed.
Terminal Phase Elimination Half-life (t1/2) Baseline to Day 36 Terminal phase elimination half-life (t1/2) will be assessed.
Apparent Terminal Phase Elimination Constant (β) Baseline to Day 36 Apparent terminal phase elimination constant (β) will be assessed.
Area Under the Plasma Concentration-time Curve (AUC) Baseline to Day 36 AUC will be assessed.
Area Under the Plasma Concentration-time Curve from Time 0 Until the Last Measurable Concentration (AUCt) Baseline to Day 36 AUCt will be assessed.
Maximum Observed Plasma Concentration (Cmax) Baseline to Day 36 Cmax will be assessed.
Area Under the Plasma Concentration-time Curve from Time 0 Until Infinity (AUCinf) Baseline to Day 36 AUCinf will be assessed.
Number of Participants with Adverse Events (AEs) Baseline to Day 66 An 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Acpru /Id# 251279
🇺🇸Grayslake, Illinois, United States
Acpru /Id# 251279🇺🇸Grayslake, Illinois, United States