Clinical trial NCT02575482: A Study to Investigate the Safety, Tolerability and Pharmacokinetics of SUVN-D4010 in Healthy Subjects
Official title: A Single-center, Double-blind, Placebo-controlled, Randomized, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SUVN-D4010 After Single Ascending Doses and Multiple Ascending Doses in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cognitive Disorders
Keywords: SUVN-D4010
serotonin 4 (5-HT4) receptor
first in human
safety
pharmacokinetics
tolerability
single dose
repeat dose
Lead sponsor: Suven Life Sciences Limited
Sponsor class: INDUSTRY
First posted: 2015-10-14
Enrollment: 64
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: ECG
timeFrame: Range of Day 1-17
measure: Physical exams
timeFrame: Range of Day 1-17
measure: Vitals signs
timeFrame: Range of Day 1-17
measure: CSSRS (suicidality)
timeFrame: Range of Day 1-17
measure: Safety and tolerability of single or multiple doses of SUVN-D4010 in healthy male subjects
timeFrame: Range of Day 1-17
Secondary outcomes:
measure: Area under the SUVN-D4010 plasma concentrationtime curve in a dosing interval (AUC0tau)
timeFrame: Day 1
measure: Area under the SUVN-D4010 plasma concentrationtime curve from zero to infinity (AUC0inf)
timeFrame: Day 14
measure: Maximum observed concentration (Cmax) and time of observation (tmax)
timeFrame: Day 1 and Day 14
measure: Oral clearance (CL/F)
timeFrame: Day 1 and Day 14
measure: Accumulation index following multiple dosing of SUVN-D4010 (AI)
timeFrame: Day 14
measure: Elimination half life (t½)
timeFrame: Day 1 and Day 14
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: PRA Health Sciences
state: Kansas
Study officials:
affiliation: Research Physician
name: Daniel Dickerson
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nirogi R, Bhyrapuneni G, Muddana NR, Goyal VK, Pandey SK, Mohammed AR, Ravula J, Jetta S, Palacharla VRC. First-in-Human Studies to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Novel 5-HT4 Partial Agonist, SUVN-D4010, in Healthy Adult and Elderly Subjects. Clin Drug Investig. 2021 May;41(5):469-482. doi: 10.1007/s40261-021-01027-4. Epub 2021 Mar 31.