Overview

First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC0194-0499 in Male Subjects With Overweight or Obesity

Status:
Completed
Trial end date:
2017-10-26
Target enrollment:
0
Participant gender:
Male
Summary
This trial is conducted in The United States of America. The aim of this trial is to investigate Safety, Tolerability and Pharmacokinetics (the exposure of the trial drug in the body) of NNC0194-0499 in Male Subjects with Overweight or Obesity.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novo Nordisk A/S
Criteria
Inclusion Criteria:

- Male, aged 22-55 years (both inclusive) at the time of signing informed consent

- Body mass index (BMI) between 25.0 and 34.9 kg/m^2 (both inclusive). Overweight should
be due to excess adipose tissue, as judged by the investigator

Exclusion Criteria:

- Any concomitant illness or disorder, which in the investigator's opinion might
jeopardise the subject's safety or compliance with the protocol

- Subjects aged above or equal to 40 years with an estimated 10-year atherosclerotic
cardiovascular disease (ASCVD according to ACC/AHA (American College of Cardiology
/American Heart Association) guideline) risk above or equal to 5%

- Male subjects who are not sexually abstinent or surgically sterilised (vasectomy) and
are sexually active with female partner(s) and who are not using a highly effective
method of contraception (such as condom with spermicide) combined with a highly
effective method of contraception for their non-pregnant female partner(s) (Pearl
Index below 1%, such as implants, injectables, oral contraceptives, intrauterine
devices, diaphragm or cervical cap+spermicide), and/or intend to donate sperm in the
period from screening (visit 1) until 3 months following administration of the
investigational medical product

- Use of prescription or non-prescription medicinal products including herbal products
and non-routine vitamins, within 2 weeks prior to screening, with the exception of
occasional use of acetaminophen, ibuprofen or acetylsalicylic acid