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

Suven Life Sciences

Status and phase: Enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: SUVN-I6107

Study type: Interventional

Funder types: Industry

Identifiers

NCT06705088

S1-I6107

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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64 participants in 2 patient groups

Single Ascending Dose

Experimental group

Description:

single ascending doses administered orally

Treatment:

Drug: SUVN-I6107

Drug: Placebo

Multiple Ascending Dose

Experimental group

Description:

multiple ascending doses administered orally for 14 days.

Treatment:

Drug: SUVN-I6107

Drug: Placebo