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

NCT04896632 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2023-09-28

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

INE 963

Part A: Single ascending dose with 7 planned cohorts\> Part B: multiple dose with 2 planned cohort q24x3 days

OTHER

Placebo

Part A: single ascending dose with 7 planned cohorts. Part B: multiple dose with 2 planned q24x3 days.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-13
Primary Completion
2022-11-24
Completion
2022-11-24

Countries

  • United Kingdom

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04896632 on ClinicalTrials.gov