COVID-19 infectious disease caused by the SARS-CoV-2 virus (coronavirus)
Conditions
Interventions
How much and how often the study compound is given:
Part A:
Group 1 will receive 80 mg EGT710 or placebo once on day 1 as oral capsules
under fasted conditions.
Group 2 will receive 240 mg of EGT710
Sponsors
Novartis Pharma AG
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: • Able and willing to provide written informed consent. • Healthy male or female participants 18 to 65 years of age, inclusive, at the time of screening, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening and baseline. • Participants must weigh at least 50 kg at screening and baseline to participate in the study, and must have a body mass index (BMI) of less than or equal to 35.0 kg/m2. BMI = Body weight (kg) / [Height (m)]2. Further criteria apply, see protocol.
Exclusion criteria
Exclusion criteria: •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant. All potential female participants will be considered physiologically able to become pregnant UNLESS they have had: (i) 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age-appropriate amenorrhea, history of vasomotor symptoms) or (ii) surgical bilateral oophorectomy (with or without hysterectomy) or total hysterectomy at least six weeks prior to screening with confirmatory FSH measurements at screening. • Sexually active males unwilling to use a condom during intercourse while taking study treatment and for 4 weeks after stopping study treatment. A condom is required for all sexually active male participants to prevent them from fathering a child AND to prevent delivery of study treatment via seminal fluid to their partner. In addition, male participants must not donate sperm for the time period specified above. • Significant illness which has not completely resolved within one (1) week prior to initial dosing. •Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment (if known), or within 30 days, whichever is longer; or longer if required by local regulations. Further criteria apply, see protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • To assess the safety and tolerability of EGT710 following administration of single and multiple oral doses. | — |
Secondary
| Measure | Time frame |
|---|---|
| • To evaluate the pharmacokinetics of EGT710 following administration of single and multiple oral doses. • To estimate the relative bioavailability of EGT710 following a single dose administration of Formulation 2 (test formulation) relative to Formulation 1 (reference formulation) under fasting conditions. • To evaluate the effect of food on the PK of EGT710 following administration of a single oral dose. | — |
Countries
Netherlands
Outcome results
None listed