An open-label, two-part study to investigate the drug-drug interaction potential of INE963 and KAE609 administered together, and the effect of food on pharmacokinetics and safety of INE963 in healthy participants.
- Conditions
- MalariaInfections and Infestations
- Registration Number
- ISRCTN17232240
- Lead Sponsor
- ovartis Pharmaceuticals UK Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 30
1. Signed informed consent
2. Healthy male and female* participants of non-childbearing potential * aged 18 to 55 years (inclusive)
3. In good health as determined by medical history, physical examination, vital signs, ECG, and laboratory test at Screening or Baseline
4. Vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed at Screening or Baseline in the supine position after at
least five minutes rest in a quiet environment. Supine vital signs must be within the following ranges:
• oral body temperature between 35.0°C and 37.5°C
• systolic blood pressure between 90 mmHg and 140 mmHg
• diastolic blood pressure between 50 mmHg and 90 mmHg
• pulse rate between 45 bpm and 90 bpm
5. Participants must weigh at least 50 kg with a body mass index (BMI) within the range of 18.0 kg/m²- 29.9 kg/m². BMI = Body weight (kg) / [Height (m)]², inclusive.
1. Significant illness which has not resolved within two (2) weeks prior to initial dosing.
2. A history of clinically significant ECG abnormalities, or any other ECG abnormalities considered clinically significant by the Investigator
at Screening and/or Baseline, including but not limited to:
• QTcF > 450 msec (males)
• QTcF > 460 msec (females)
3. Any clinically significant hematology parameters outside normal ranges as defined by the local laboratory at Screening and/or Baseline.
Participants with neutrophils <1.5 x 10^9/L should be excluded.
4. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which
may jeopardize the participant in case of participation in the study. The Investigator should make this determination in consideration of the
participant's medical history and/or clinical or laboratory evidence including but not restricted to any of the following at Screening or
Baseline:
4.1. Use of any prescription drugs, over-the-counter (OTC) medication, herbal supplements, prescribed medicinal use of cannabis/marijuana,
within four weeks prior to initial dosing, with the exception of coronavirus disease 2019 (COVID-19) vaccine which will be restricted within 2 weeks prior to first dosing.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Primary plasma PK parameters (AUClast, AUCinf and Cmax) for INE963 and KAE609<br> Primary plasma PK parameters (Cmax, AUClast, AUCinf and Tmax) for INE963<br><br> Part A Period 1: 0 h, 1 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h, 120 h, 168 h, 264 h, 360 h, and 504 h postdose of INE963<br> Part A Period 2: 0 h, 1 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h, 120 h, 168 h postdose of KAE609<br> Part A Period 3: 0 h, 1 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h, 120 h, 168 h, 264 h, 360 h, and 504 h postdose of INE963<br><br> Part B Day 1 Period 1: 0 h, 1 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h, 120 h, 168 h, 264 h, 360 h, and 504 h postdose of INE963<br> Part B Day 1 Period 2: 0 h, 1 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h, 120 h, 168 h, 264 h, 360 h, and 504 h postdose of INE963<br>
- Secondary Outcome Measures
Name Time Method <br> 1. Adverse events, physical examination findings, vital signs, ECG findings, safety laboratory assessments including chemistry, hematology, and urinalysis results.<br> 2. Additional PK parameters of INE963 and KAE609 including but not limited to: Tmax, CL/F, Vz/F and T1/2.<br>