Study of S-892216 Long-acting Injectable (LAI) in Healthy Adult Participants
Not Applicable
Recruiting
- Conditions
- Healthy Participants
- Interventions
- Drug: S-892216-LAIDrug: Placebo
- Registration Number
- NCT07093580
- Lead Sponsor
- Shionogi
- Brief Summary
The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics (PK) of single- and multiple-dose administration of S-892216-LAI in healthy adults.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 98
Inclusion Criteria
- Body mass index (BMI) ≥18.5 and ≤32.0 kilograms (kg)/square meter (m^2)
Key
Exclusion Criteria
- Presence or history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological, or ophthalmological (for example, increased intra-ocular pressure) disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data per the investigator's assessment.
- History of cancer except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
- Require medication or other treatment (for example, dietary restrictions or physical therapy).
- Participated in any other clinical study involving an investigational study intervention or any other type of medical research within 30 days, or 5 times the half-life of the investigational drug, before signing of the informed consent form (ICF) for this study or who are currently participating in such a study.
- Positive test results of the following at screening or within 6 months prior to administration of study intervention: hepatitis B surface antigen (HBsAg); hepatitis C virus antibody (HCV); and human immunodeficiency virus (HIV) antigen/antibody.
- Positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) reverse transcription polymerase chain reaction (RT-PCR) test result, positive transcription-mediated amplification test result, positive antigen test result, or any other test approved according to local regulations at check in for each period on admission.
- Known allergy/sensitivity or any hypersensitivity to components of S-892216-LAI or placebo for S-892216-LAI.
- Used cannabis (medical or recreational), tobacco, or nicotine-containing products (including e-cigarettes, pipe tobacco, cigar, chewing tobacco, nicotine patch, and nicotine gum) within 6 months prior to admission.
Note: Other protocol-defined inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1 (Single Ascending Dose) S-892216-LAI Participants will receive a single dose of S-892216-LAI or placebo on Day 1. Part 1 (Single Ascending Dose) Placebo Participants will receive a single dose of S-892216-LAI or placebo on Day 1. Part 2 (Multiple Ascending Dose) S-892216-LAI Participants will receive multiple doses of S-892216-LAI or placebo on Day 1 and Day 85 in treatment periods 1 and 2, respectively. Part 2 (Multiple Ascending Dose) Placebo Participants will receive multiple doses of S-892216-LAI or placebo on Day 1 and Day 85 in treatment periods 1 and 2, respectively.
- Primary Outcome Measures
Name Time Method Part: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Day 1 through Day 364 Part 2: Number of Participants With TEAEs Day 1 through Day 448
- Secondary Outcome Measures
Name Time Method Part 2: Tmax of S-892216 and its Metabolites Day 1 (pre-administration, up to 12 hours post-administration) through Day 70 in Treatment Period 1 and Day 85 (pre-administration, up to 12 hours post-administration) through Day 448 in Treatment Period 2 Part 1: Maximum Plasma Concentration (Cmax) of S-892216 and its Metabolites Day 1 (pre-administration, up to 12 hours post-administration) through Day 364 Part 2: Cmax of S-892216 and its Metabolites Day 1 (pre-administration, up to 12 hours post-administration) through Day 70 in Treatment Period 1 and Day 85 (pre-administration, up to 12 hours post-administration) through Day 448 in Treatment Period 2 Part 1: Time to Reach Cmax (Tmax) of S-892216 and its Metabolites Day 1 (pre-administration, up to 12 hours post-administration) through Day 364 Part 2: AUC0-last of S-892216 and its Metabolites Day 1 (pre-administration, up to 12 hours post-administration) through Day 70 in Treatment Period 1 and Day 85 (pre-administration, up to 12 hours post-administration) through Day 448 in Treatment Period 2 Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration After Dosing (AUC0-last) of S-892216 and its Metabolites Day 1 (pre-administration, up to 12 hours post-administration) through Day 364
Trial Locations
- Locations (2)
ICON Clinical Research: Lenexa
🇺🇸Lenexa, Kansas, United States
ICON Clinical Research: Salt Lake City
🇺🇸Salt Lake City, Utah, United States
ICON Clinical Research: Lenexa🇺🇸Lenexa, Kansas, United States