Cognitive Disorders
Conditions
Keywords
SUVN-D4010, serotonin 4 (5-HT4) receptor, first in human, safety, pharmacokinetics, tolerability, single dose, repeat dose
Brief summary
The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of SUVN-D4010 in healthy male subjects following single or multiple ascending doses.
Detailed description
This is a single and multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of SUVN-D4010 administered orally once a day to healthy male subjects. The study will be conducted under double blind conditions. The primary objective is to evaluate the safety and tolerability of SUVN-D4010 following oral administration of single or multiple ascending doses and estimate the maximum tolerated dose of SUVN-D4010,if possible. The secondary objectives are to evaluate the single and repeat dose plasma pharmacokinetics following oral administration of single and multiple ascending doses of SUVN-D4010 in healthy male subjects.
Interventions
DRUGSUVN-D4010
DRUGPlacebo
Sponsors
Suven Life Sciences Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male aged 18 to 45 years with a BMI between 18 and 30 kg/m2, (inclusive).
Exclusion criteria
* Standard exclusion criterion for Phase 1 clinical trial in healthy subjects. * History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate * History or presence of GI, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs as judged by Investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ECG | Range of Day 1-17 | — |
| Physical exams | Range of Day 1-17 | — |
| Vitals signs | Range of Day 1-17 | — |
| CSSRS (suicidality) | Range of Day 1-17 | Columbia Suicidal Severity Rating Scale |
| Safety and tolerability of single or multiple doses of SUVN-D4010 in healthy male subjects | Range of Day 1-17 | Incidence of Treatment-Emergent Adverse Events, Laboratory parameters |
Secondary
| Measure | Time frame |
|---|---|
| Area under the SUVN-D4010 plasma concentrationtime curve in a dosing interval (AUC0tau) | Day 1 |
| Elimination half life (t½) | Day 1 and Day 14 |
| Area under the SUVN-D4010 plasma concentrationtime curve from zero to infinity (AUC0inf) | Day 14 |
| Maximum observed concentration (Cmax) and time of observation (tmax) | Day 1 and Day 14 |
| Oral clearance (CL/F) | Day 1 and Day 14 |
| Accumulation index following multiple dosing of SUVN-D4010 (AI) | Day 14 |
Countries
United States
Outcome results
None listed