Clinical trial NCT06705088: Safety, Tolerability, Pharmacokinetics And Pharmacodynamics of SUVN-I6107 In Healthy Participants
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy
Keywords: SUVN-I6107
First-in-Human
Muscarinic M1 Receptor Positive Allosteric Modulator (M1-PAM)
Lead sponsor: Suven Life Sciences Limited
Sponsor class: INDUSTRY
First posted: 2024-11-26
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with treatment-related adverse events
timeFrame: From Day 1 to Day 11 (Segment 1) and from Day 1 to Day 24 (Segment 2)
measure: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values
timeFrame: From Baseline to Day 11 (Segment 1) and to Day 24 (Segment 2)
measure: Number of Participants With Clinically Significant Changes in Blood Pressure
timeFrame: From baseline to Day 11 (Segment 1) and to Day 24 (Segment 2)
measure: Number of Participants With Clinically Significant Changes in Pulse Rate
timeFrame: From baseline to Day 11 (Segment 1) and to Day 24 (Segment 2)
measure: Number of Participants With Clinically Significant Changes in Body Temperature
timeFrame: From baseline to Day 11 (Segment 1) and to Day 24 (Segment 2)
measure: Number of Participants With Clinically Significant Changes in Respiration Rate
timeFrame: From baseline to Day 11 (Segment 1) and to Day 24 (Segment 2)
measure: Changes in Columbia Suicide Severity Rating Scale (C-SSRS) Score
timeFrame: From baseline to Day 24 (Segment 2)
Secondary outcomes:
measure: Area under the concentration-time curve (AUC)
timeFrame: Day 1 and Day 14
measure: Maximum observed concentration (Cmax)
timeFrame: Day 1 and Day 14
measure: Time to reach maximum concentration (Tmax)
timeFrame: Day 1 and Day 14
measure: Terminal half-life (t½)
timeFrame: Day 1 and Day 14
Other outcomes:
measure: Quantitative electroencephalogram (qEEG)
timeFrame: Day 1 (Segment 1); Day 7 and Day 12 (Segment 2)
measure: Latency for parameter from the Active, Auditory Oddball Event-related potential (ERP) test
timeFrame: Day 1 (Segment 1); Day 7 and Day 12 (Segment 2)
Locations:
city: San Antonio
country: United States
facility: Clinical Research Site
state: Texas
Study officials:
References: