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

A First-In-Human, Randomized, Double-Blind, Placebo-Controlled, Single And Multiple Ascending Oral Dose Study Of SUVN-I6107 To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics In Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: SUVN-I6107; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78209
      • Clinical Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment-related adverse events	Number of participants with adverse events (AE), discontinuations due to AE or serious adverse event [SAE], and withdrawals from the study due to AE.	From Day 1 to Day 11 (Segment 1) and from Day 1 to Day 24 (Segment 2)
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values	Descriptive statistics of QTcF for observed values and changes from baseline will be summarized at each scheduled time point.	From Baseline to Day 11 (Segment 1) and to Day 24 (Segment 2)
Number of Participants With Clinically Significant Changes in Blood Pressure		From baseline to Day 11 (Segment 1) and to Day 24 (Segment 2)
Number of Participants With Clinically Significant Changes in Pulse Rate		From baseline to Day 11 (Segment 1) and to Day 24 (Segment 2)
Number of Participants With Clinically Significant Changes in Body Temperature		From baseline to Day 11 (Segment 1) and to Day 24 (Segment 2)
Number of Participants With Clinically Significant Changes in Respiration Rate		From baseline to Day 11 (Segment 1) and to Day 24 (Segment 2)
Changes in Columbia Suicide Severity Rating Scale (C-SSRS) Score	The C-SSRS includes 'yes' or 'no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present (from 1 to 5, with 5 being the most severe). Greater lethality or potential lethality of suicidal behaviors (endorsed on the behavior subscale) indicates increased risk.	From baseline to Day 24 (Segment 2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the concentration-time curve (AUC)	SUVN-I6107 concentrations levels will be assessed after single and multiple ascending oral doses.	Day 1 and Day 14
Maximum observed concentration (Cmax)	SUVN-I6107 maximum observed concentration will be assessed after single and multiple ascending oral doses.	Day 1 and Day 14
Time to reach maximum concentration (Tmax)	Time to reach maximum concentration will be assessed after single and multiple ascending oral doses.	Day 1 and Day 14
Terminal half-life (t½)	SUVN-I6107 elimination rate will be assessed after single and multiple ascending oral doses.	Day 1 and Day 14

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative electroencephalogram (qEEG)	Change in absolute quantitative electroencephalogram (qEEG) power from predose to postdose.	Day 1 (Segment 1); Day 7 and Day 12 (Segment 2)
Latency for parameter from the Active, Auditory Oddball Event-related potential (ERP) test	Change in latency (in milliseconds) for the P300 parameter from the Active, Auditory Oddball ERP test from predose to postdose.	Day 1 (Segment 1); Day 7 and Day 12 (Segment 2)

Collaborators and Investigators

• Sponsor: Suven Life Sciences Limited

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2025
• Primary Completion (Actual): December 2, 2025
• Study Completion (Actual): December 2, 2025

Study Registration Dates

• First Submitted: November 14, 2024
• First Submitted That Met QC Criteria: November 25, 2024
• First Posted (Actual): November 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: First-in-Human; SUVN-I6107; Muscarinic M1 Receptor Positive Allosteric Modulator (M1-PAM)
• Other Study ID Numbers: S1-I6107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No