A randomized, blinded, placebo-controlled study to assess the safety, tolerability and pharmacokinetics of EGT710 following administration of single and multiple doses to healthy adults.

Completed

Conditions: COVID-19
infectious disease caused by the SARS-CoV-2 virus (coronavirus)
10047438

Registration Number: NL-OMON53410

Lead Sponsor: ovartis Pharma AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 100

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

•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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• To assess the safety and tolerability of EGT710 following administration of<br /><br>single and multiple oral doses.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• To evaluate the pharmacokinetics of EGT710 following administration of single<br /><br>and multiple oral doses.<br /><br>• To estimate the relative bioavailability of EGT710 following a single dose<br /><br>administration of Formulation 2 (test formulation) relative to Formulation 1<br /><br>(reference formulation) under fasting conditions.<br /><br>• To evaluate the effect of food on the PK of EGT710 following administration<br /><br>of a single oral dose.</p><br>