Safety, Tolerability, Pharmacokinetics And Pharmacodynamics of SUVN-I6107 In Healthy Participants

Purpose

The purpose of this study is 1) to investigate how safe and tolerable SUVN-I6107 is after a single oral dose at increasing dose levels and multiple oral doses at increasing dose levels, 2) to determine the pharmacokinetic (PK) profile after single and multiple ascending oral doses, 3) to investigate the effects of food on SUVN-I6107 pharmacokinetics and 4) to evaluate the pharmacodynamic (PD) effects of single and multiple ascending oral doses of SUVN-I6107 on quantitative electroencephalogram (qEEG) and event-related potential (ERP) assessments.

Condition

  • Healthy

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Body mass index (BMI): 18.0 to 30.0 kg/m2 for Segment 1 and 18.0 to 32.0 kg/m2 for Segment 2, inclusive, at screening and weight at least 50 kg and no more than 100 kg. - Ability and willingness to abstain from alcohol-, caffeine-, and methylxanthine-containing beverages or food (eg, coffee, tea, cola, chocolate, energy drinks) from 48 hours (2 days) prior to each admission to the clinical facility until study discharge. - All values for hematology and clinical chemistry tests of blood and urine within the normal range or showing no clinically relevant deviations, as judged by the Investigator, at screening and at admission.

Exclusion Criteria

  • Females who are pregnant, lactating, planning to become pregnant, or planning to donate ova/oocytes during this study or within 30 days after last administration of study drug. - Males with female partners who are pregnant, lactating, or planning to become pregnant during this study or within 90 days after dosing of study drug. - Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of admission to the clinical site.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Single Ascending Dose 		single ascending doses administered orally
  • Drug: SUVN-I6107
    SUVN-I6107 Tablet
  • Drug: Placebo
    A look-alike tablet with no active ingredient.
Experimental
Multiple Ascending Dose 		multiple ascending doses administered orally for 14 days.
  • Drug: SUVN-I6107
    SUVN-I6107 Tablet
  • Drug: Placebo
    A look-alike tablet with no active ingredient.

Recruiting Locations

Clinical Research Site
San Antonio 4726206, Texas 4736286 78209

More Details

Status
Recruiting
Sponsor
Suven Life Sciences Limited

Study Contact

Ramakrishna Nirogi
+9140 2319 3956
nvsrk@suven.com

Detailed Description

This research study is a randomized, single-center, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD), first-in-human study in healthy participants. This study consist of 2 segments: Segment 1 will be the SAD portion and Segment 2 will be the MAD portion. Segment 1 will include up to 5 sequential cohorts. Up to 40 healthy male or female subjects, ages 18 - 45 years (inclusive) old at screening will be enrolled. Segment 2 will include up to 3 sequential cohorts. The dosing will be administered for 14 consecutive days. Up to 24 healthy male or female subjects, ages 50 to 80 years (inclusive) old at screening will be enrolled.