Clinical trial NCT02342041: A Study to Investigate the Safety, Tolerability and Pharmacokinetics of SUVN-G3031 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-G3031 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-G3031
histamine 3 (H3) receptor inverse agonist
first in human
safety
pharmacokinetics
tolerability
single dose
repeat dose
Lead sponsor: Suven Life Sciences Limited
Sponsor class: INDUSTRY
First posted: 2015-01-19
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-G3031 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-G3031 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-G3031 following oral administration of single or multiple ascending doses and estimate the maximum tolerated dose of SUVN-G3031, 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-G3031 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: Safety and tolerability of single or multiple doses of SUVN-G3031 in healthy male subjects
timeFrame: Range of Day 1-19
Secondary outcomes:
measure: Area under the SUVN-G3031 plasma concentration-time curve in a dosing interval (AUC0-tau)
timeFrame: Day 1
measure: Area under the SUVN-G3031 plasma concentration-time curve from zero to infinity (AUC0-inf)
timeFrame: Day 14
measure: Maximum observed concentration (Cmax) and time of observation (tmax)
timeFrame: Day 1 and Day 14
measure: Oral clearance (CL/F), apparent volume of distribution (Vz/F), and elimination half life (t½)
timeFrame: Day 1 and Day 14
measure: Accumulation index following multiple dosing of SUVN-G3031 (AI)
timeFrame: Day 14
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Quintiles
state: Kansas
Study officials:
affiliation: Senior Medical Research Director
name: Murtaugh Thomas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nirogi R, Mudigonda K, Bhyrapuneni G, Muddana NR, Shinde A, Goyal VK, Pandey SK, Mohammed AR, Ravula J, Jetta S, Palacharla VRC. Safety, Tolerability, and Pharmacokinetics of SUVN-G3031, a Novel Histamine-3 Receptor Inverse Agonist for the Treatment of Narcolepsy, in Healthy Human Subjects Following Single and Multiple Oral Doses. Clin Drug Investig. 2020 Jul;40(7):603-615. doi: 10.1007/s40261-020-00920-8.