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

NCT04896632 | Terminated Phase 1

• 1 other identifier: CINE963A02101
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Number of Subjects with Significant Clinical Safety Labs, reporting SAEs and AEs and ECG findings

  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

  Dose escalation (21 days)

Secondary Outcomes (11)

• INE963 pharmacokinetic parameters AUC in SAD Part

  Day 1, 2, 3, 4, 6, 8, 9, 12 and 16

• INE963 pharmacokinetic parameters Tmax in SAD Part

  Day 1, 2, 3, 4, 6, 8, 9, 12 and 16

• INE963 pharmacokinetic parameters Cmax in SAD Part

  Day 1, 2, 3, 4, 6, 8, 9, 12 and 16

• INE963 pharmacokinetic parameters Vz/F in SAD Part

  Day 1, 2, 3, 4, 6, 8, 9, 12 and 16

• INE963 pharmacokinetic parameters T1/2 in SAD Part

  Day 1, 2, 3, 4, 6, 8, 9, 12 and 16

Study Arms (2)

INE963

EXPERIMENTAL

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

Drug: INE 963

Placebo group

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

INE 963 DRUG

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

INE963

Placebo OTHER

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

Placebo group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Written informed consent must be obtained before any assessment is performed.
• Healthy male and female participants 18 to 55 years of age inclusive, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
• At screening and baseline, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed in the supine position Supine vital signs should be within the following ranges:
• oral body temperature between 35.0 - 37.5 °C
• systolic blood pressure, 90 - 140 mm Hg
• diastolic blood pressure, 50 - 90 mm Hg
• pulse rate, 40 - 90 bpm If vital signs are outside these ranges, the investigator may obtain up to 2 additional readings so that a total of up to 3 consecutive assessments are made. At least the last reading must be within the ranges provided above in order for the participant to qualify.
• Participants must weigh at least 50 kg at screening and baseline to participate in the study, and must have a body mass index (BMI) within the range of 18.0 - 32.0 kg/m2. BMI = Body weight (kg) / \[Height (m)\]2
• Able to communicate well with the investigator, to understand and comply with the requirements of the study.

You may not qualify if:

• History of hypersensitivity to any of the study treatments or excipients or to drugs of similar chemical classes
• Significant illness which has not resolved within two (2) weeks prior to initial dosing.
• Recent (within the last three years of screening) and/or recurrent history of autonomic dysfunction (e.g., recurrent episodes of fainting, palpitations, etc.).
• Recent (within the last three years of screening) and/or recurrent history of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).
• Known history or current clinically significant arrhythmias.
• Known family history or known presence of long QT syndrome.
• A history of clinically significant ECG abnormalities, or any of the following ECG abnormalities at screening and/or baseline:
• PR \> 220 msec
• QRS complex \> 120 msec
• RR \>1.5 seconds
• QTcF \> 450 msec (males)
• QTcF \> 460 msec (females)
• History of immunodeficiency diseases, including a positive HIV test result.
• Chronic infection with Hepatitis B (HBV) or Hepatitis C (HCV). A positive HBV surface antigen (HBsAg) test, excludes a participant. Participants with a positive HCV antibody test should have HCV RNA levels measured. Participants with positive (detectable) HCV RNA should be excluded.
• History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in-situ cervical cancer), treated or untreated, within the past 5 years of screening, regardless of whether there is evidence of local recurrence or metastases.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Mere Way, Nottingham, NG11 6JS, United Kingdom

Location

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: May 21, 2021
• Study Start: May 13, 2021
• Primary Completion: November 24, 2022
• Study Completion: November 24, 2022
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)