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

Launched by SUVEN LIFE SCIENCES LIMITED · Nov 25, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called SUVN-I6107 to see how safe it is for healthy participants. The researchers want to find out if the medication is well-tolerated when taken as a single dose or multiple doses, and how it behaves in the body after these doses. They will also look at how eating food affects the medication and measure its impact on brain activity using special tests.

To participate, individuals must be between 18 and 55 years old, have a healthy body weight, and be willing to avoid certain foods and drinks like coffee and energy drinks for a couple of days before each visit. It's important to note that pregnant or breastfeeding women, as well as those with certain health issues or recent significant medical events, cannot join the study. Participants can expect to receive careful monitoring and support throughout the trial, helping researchers learn more about SUVN-I6107 and its effects.

Gender

ALL

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.