Cryptosporidium infections Infections and Infestations Cryptosporidiosis
Conditions
Interventions
This is a first-in-human study to evaluate the safety, tolerability, and pharmacokinetics of single ascending doses and multiple ascending doses of EDI048 administered orally in healthy volunteers.
Sponsors
Novartis Pharma AG (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy male and female participants 18 to 55 years of age included, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening. 2. Participants must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18.0 - 30.0 kg/m². BMI = Body weight (kg) / [Height (m)]² 3. At screening and baseline, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed in the supine position after the participant has rested for at least three (3) minutes, and again in the standing position. Supine vital signs should be within the following ranges: 4. Oral body temperature between 35.0-37.5 °C 5. Systolic blood pressure, 90-139 mmHg 6. Diastolic blood pressure, 50-89 mmHg 7. Pulse rate, 40-90 bpm
Exclusion criteria
Exclusion criteria: 1. Participants who have received any IMP in a clinical research study within 90 days or 5 half-lives of enrollment, whichever is longer; or longer if required by local regulations. 2. History of multiple and recurring allergies or allergy or hypersensitivity to any of the study treatments, excipients or drugs of similar chemical classes. Hay fever is allowed unless it is active at time of screening or if there is a risk that it may become active during the study. 3. Pregnant or nursing (lactating) women, assessed at screening and baseline. 4. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant. 5. Sexually active males unwilling to use a condom during intercourse while taking investigational drug and for 7 days after stopping the investigational drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Adverse events (to assess tolerability of the test medicine) will be collected by often asking the volunteers how they are feeling, from the start of the trial until follow up. 2. Additional safety assessments (e.g. vital signs, ECGs and laboratory safety tests) will be performed using standard phase 1 unit monitoring methods from start of screening until the end of the study. Volunteers will be in the study for approximately 65 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood samples will be collected and the pharmacokinetics of the test medicine in plasma will be serially assessed, after a single dose, and after repeated doses (administered twice daily for 5.5 days) up to 48 hrs post last dose (day 6 morning dose only), using LC-MS/MS bioanalytical assay method. | — |
Countries
England, United Kingdom
Outcome results
None listed