Open-label study to investigate pharmacokinetics, mass balance and metabolite profiles of NRD135S.E1 in healthy adult male volunteers

ovaremed AG (Switzerland)0 sites8 target enrollmentMarch 9, 2022

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Pharmacokinetics, mass balance and metabolite profiles of NRD135S.E1 in healthy adult male volunteers
Sponsor: ovaremed AG (Switzerland)
Enrollment: 8
Status: Completed
Last Updated: 2 years ago

No summary available.

Registry

who.int

Start Date

March 9, 2022

End Date

April 15, 2022

Last Updated

2 years ago

Study Type

Interventional

Sex

Male

Sponsor

ovaremed AG (Switzerland)

•1\. Healthy males
•2\. Aged 30 to 65 years inclusive at the time of signing informed consent
•3\. Body mass index (BMI) of \=18\.0 kg/m² and \<30\.0 kg/m² as measured at screening
•4\. Must be willing and able to communicate and participate in the whole study
•5\. Must be willing to consume the drug formulation that contains a small amount of alcohol
•6\. Must have regular bowel movements (i.e. average stool production of \=1 and \=3 stools per day )
•7\. Must provide written informed consent
•8\. Must agree to adhere to the contraception requirements defined in the clinical protocol

•1\. Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1, or less than 5 elimination half\-lives prior to Day 1, whichever is longer
•2\. Subjects who are, or are immediate family members of, a study site or sponsor employee
•3\. Evidence of current SARS\-CoV\-2 infection within 2 weeks of first IMP administration or current ongoing symptoms from previous SARS\-CoV\-2 infection
•4\. History of any drug or alcohol abuse in the past 2 years
•5\. Regular alcohol consumption in males \>21 units per week (1 unit \= ½ pint beer, or a 25 mL shot of 40% spirit, 1\.5 to 2 units \= 125 mL glass of wine, depending on type)
•6\. A confirmed positive alcohol breath test at screening or admission
•7\. Current smokers and those who have smoked within the last 6 months. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission
•8\. Current users of e\-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
•9\. Male subjects with pregnant or lactating partners
•10\. Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x\-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, shall participate in the study