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

Phase 1

Terminated

• Conditions: Healthy Volunteers
• Interventions: Drug: INE 963; Other: Placebo

• Registration Number: NCT04896632
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-05-12
• Study Start: 2021-05-13
• Study First Submitted QC: 2021-05-20
• Study First Posted: 2021-05-21
• Primary Completion: 2022-11-24
• Study Completion: 2022-11-24
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-26
• Last Update Posted: 2023-09-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
INE963	INE 963	Part A is a single ascending dose (SAD) study with 7 planned cohorts Part B is a multiple dose (MD) study with 2 planned cohort q24h x 3 day of either INE963 or placebo
Placebo group	Placebo	Part A is a single ascending dose (SAD) study with 7 planned cohorts Part B is a multiple dose (MD) study with 2 planned cohort q24h x 3 day of either INE963 or placebo

Primary Outcome Measures

Name	Time	Method
Number of Subjects with Significant Clinical Safety Labs, reporting SAEs and AEs and ECG findings	Dose escalation (21 days)	Number of Subjects with Significant Clinical Safety Labs, reporting SAEs and AEs and ECG findings, as judged by investigator at each dose escalation review meetings

Secondary Outcome Measures

Name	Time	Method
INE963 pharmacokinetic parameters T1/2 in SAD Part	Day 1, 2, 3, 4, 6, 8, 9, 12 and 16	INE963 pharmacokinetic parameters in SAD Part (T1/2) at the specific timepoints
INE963 pharmacokinetic parameters in MAD Part (Cmax)	Day 1, 2, 3, 4, 6, 8, 10, 11, 14 and Day 18	INE963 pharmacokinetic parameters in MAD Part (Cmax) measured at specific timepoints
Baseline AAG concentration	Baseline	Alpha-1- acid glycoprotein (AAG) level will be taken at baseline for Part A and Part b.
INE963 pharmacokinetic parameters AUC in SAD Part	Day 1, 2, 3, 4, 6, 8, 9, 12 and 16	INE963 pharmacokinetic parameters (AUC) in SAD Part at specified timepoints
INE963 pharmacokinetic parameters in MAD Part (T1/2)	Day 1, 2, 3, 4, 6, 8, 10, 11, 14 and Day 18	INE963 pharmacokinetic parameters in MAD Part (T1/2) measured at specific timepoints
INE963 pharmacokinetic parameters Tmax in SAD Part	Day 1, 2, 3, 4, 6, 8, 9, 12 and 16	INE963 pharmacokinetic parameters in SAD Part (Tmax) at the specific timepoints
INE963 pharmacokinetic parameters Cmax in SAD Part	Day 1, 2, 3, 4, 6, 8, 9, 12 and 16	INE963 pharmacokinetic parameters (Cmax) in SAD Part at specified timepoints
INE963 pharmacokinetic parameters Vz/F in SAD Part	Day 1, 2, 3, 4, 6, 8, 9, 12 and 16	INE963 pharmacokinetic parameters in SAD Part (Vz/F) at the specific timepoints
INE963 pharmacokinetic parameters in MAD Part (AUC)	Day 1, 2, 3, 4, 6, 8, 10, 11, 14 and Day 18	INE963 pharmacokinetic parameters in MAD Part (AUC) measured at specific timepoints
INE963 pharmacokinetic parameters in MAD Part (Tmax)	Day 1, 2, 3, 4, 6, 8, 10, 11, 14 and Day 18	INE963 pharmacokinetic parameters in MAD Part (Tmax) measured at specific timepoints
INE963 pharmacokinetic parameters in MAD Part (Vz/F)	Day 1, 2, 3, 4, 6, 8, 10, 11, 14 and Day 18	INE963 pharmacokinetic parameters in MAD Part (Vz/F) measured at specific timepoints

Trial Locations

Locations (1)

Novartis Investigative Site; 🇬🇧 Mere Way, Nottingham, United Kingdom