Study of Safety, Tolerability, and Pharmacokinetics of INE963 in Healthy Participants

Healthy Volunteers Clinical Trial

Official title: A Randomized, Participant- and Investigator-blinded, Placebo-controlled, Single Ascending Dose and Multiple Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of INE963 in Healthy Participants

Status Terminated

Clinical Trial Summary

The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of single ascending doses and multiple doses of INE963 given orally in healthy participants.

Clinical Trial Description

This is a randomized, participant- and investigator-blinded, placebo-controlled, single ascending and multiple oral dose study in healthy participants. The study consisted of two parts:

• Part A was a single ascending dose (SAD) study with 6 planned cohorts: (A1, A2, A4, A5, A6 and A7) of 8 participants each and 1 cohort (A3) with 10 participants, as randomization ratio 4:1 was originally planned due to the food effect cohort. There was also an optional cohort of 8 subjects (A8).

• Part B was a multiple dose (MAD) study with 2 planned cohort of 9 participants (B1 and B2; randomization ratio 2:1). There was also an optional cohort of 9 subjects (B3).

Cohort B2 and Optional Cohorts A8 and B3 were not dosed since the study was terminated early as per joint decision between the Principal Investigator and the Sponsor. Importantly, the decision to terminate the study early was not taken as a consequence of any safety concerns seen with INE963 administration in healthy volunteers. ;

Related Conditions & MeSH terms

• Healthy Volunteers

• NCT number: NCT04896632
• Study type: Interventional
• Source: Novartis
• Status: Terminated
• Phase: Phase 1
• Start date: May 13, 2021
• Completion date: November 24, 2022