Malaria Infections and Infestations
Conditions
Interventions
This study is in 2 parts i.e. a drug – drug interaction part (Part A) and then a food effect part (Part B). Part A will look at the effect of taking the 2 study medicines (INE963 and KAE609) together,
Sponsors
Novartis Pharmaceuticals UK Limited
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary plasma PK parameters (AUClast, AUCinf and Cmax) for INE963 and KAE609 Primary plasma PK parameters (Cmax, AUClast, AUCinf and Tmax) for INE963 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 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 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 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 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Adverse events, physical examination findings, vital signs, ECG findings, safety laboratory assessments including chemistry, hematology, and urinalysis results. 2. Additional PK parameters of INE963 and KAE609 including but not limited to: Tmax, CL/F, Vz/F and T1/2. | — |
Countries
United Kingdom
Outcome results
None listed