Investigating the safety and effects of SUVN-I6107 in healthy individuals
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
This study is testing a new drug called SUVN-I6107 in healthy adults to see if it is safe and how it affects the brain.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Suven Life Sciences Limited Industry-sponsored |
| Locations | 1 site (San Antonio, Texas) |
| Trial ID | NCT06705088 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of SUVN-I6107, a muscarinic M1 receptor positive allosteric modulator, in healthy participants. The study is divided into two segments: the first segment involves single ascending doses administered to younger healthy adults, while the second segment involves multiple ascending doses given to older healthy adults over 14 consecutive days. Participants will undergo various assessments, including quantitative electroencephalogram (qEEG) and event-related potential (ERP) evaluations, to understand the drug's effects. The study is randomized, double-blind, and placebo-controlled to ensure robust results.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy male and female adults aged 18 to 45 years for the first segment and aged 50 to 80 years for the second segment.
Not a fit: Patients who are pregnant, lactating, or planning to become pregnant, as well as those with significant health deviations, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the safety and pharmacological effects of SUVN-I6107, potentially leading to new treatments for conditions related to the muscarinic M1 receptor.
How similar studies have performed: While this is a first-in-human study, similar pharmacological approaches have shown promise in other studies, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
San Antonio, Texas
- Clinical Research Site — San Antonio, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Ramakrishna Nirogi
- Email: nvsrk@suven.com
- Phone: +9140 2319 3956
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.