NCT03031574CompletedPhase 1
A Phase 1, Single-Center, Single-Dose, 2-Way Crossover, Randomized Food-Effect and Non-Randomized Gender- and Age- Effect Pharmacokinetic Study of SUVN-D4010 Orally Administered in Healthy Subjects
Suven Life Sciences Limited1 site in 1 country28 target enrollmentStarted: January 23, 2017Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Suven Life Sciences Limited
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Area under concentration (AUC)
Study Overview
Brief Summary
The purpose of the study is to evaluate the effect of food, gender, and age on the single-dose pharmacokinetics (PK) of SUVN-D4010.
Detailed Description
The main objective of the study is to evaluate the safety and tolerability of orally administered SUVN-D4010 under single-dose conditions in healthy adult male and female subjects and healthy elderly male subjects.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy male subjects, aged 18 to 45 years, inclusive; healthy female subjects, aged 18 to 45 years, inclusive; healthy elderly male subjects, aged ≥65 years.
- •Have a body mass index (BMI) between 18.0 and 30.0kg/m2 (inclusive) and weigh at least 50 kg and no more than 100 kg.
Exclusion Criteria
- •History or presence of gastrointestinal, hepatic, or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- •Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the (first) administration of the study drug.
- •Any positive result at Screening for serum hepatitis B surface antigen, hepatitis C virus antibody, and human immunodeficiency virus antibody.
- •Plasma or blood product donation within 1 month of the (first) administration of the study drug and any blood donation/blood loss more than 500 mL within the 2 months prior to the (first) administration of the study drug.
- •As judged by the Investigator that the subject should not participate in the study if he/she is considered unlikely to comply with study procedures, restrictions, and requirements.
Arms & Interventions
Food Effect
Active Comparator
SUVN-D4010 tablets single dose
Intervention: SUVN-D4010 (Drug)
Gender Effect
Active Comparator
SUVN-D4010 tablets single dose
Intervention: SUVN-D4010 (Drug)
Age Effect
Active Comparator
SUVN-D4010 tablets single dose
Intervention: SUVN-D4010 (Drug)
Outcomes
Primary Outcomes
Area under concentration (AUC)
Time Frame: 72 hours
Maximum observed concentration (Cmax)
Time Frame: Day 1
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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