Investigation on Safety, Tolerability and Pharmacokinetics of Single Doses of NNC0174-0833 in Normal Weight, Overweight to Obese But Otherwise Healthy Male Subjects

Obesity Clinical Trial

Official title:

Investigation on Safety, Tolerability and Pharmacokinetics of Single Doses of NNC0174-0833 in Normal Weight, Overweight to Obese But Otherwise Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02300844
• Other study ID #: NN9838-3993
• Secondary ID: U1111-1131-7160
• Status: Completed
• Phase: Phase 1
• First received: November 21, 2014
• Last updated: January 23, 2018
• Start date: December 1, 2014
• Est. completion date: March 21, 2016

Study information

• Verified date: January 2018
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in the United States of America (USA). The aim of this trial is to investigate the safety, tolerability and pharmacokinetics of single doses of NNC0174-0833 in normal weight, overweight to obese but otherwise healthy male subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: March 21, 2016
• Est. primary completion date: March 21, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 22 Years to 64 Years

Eligibility

Inclusion Criteria:

• Normal weight, Overweight or obese (Body Mass Index [BMI]) between or equal to 20.0 and 35.0 kg/m^2 but otherwise healthy men

• Age between or equal to 22 and 64 years at the time of signing informed consent

Exclusion Criteria:

• History of, or presence of, cancer, diabetes or any clinically significant cardiovascular,respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders including sleep apnoea, as judged by the investigator

• Subjects with history of, or presence of, a disease being associated with impaired calcium homeostasis and/or increased bone turnover (e.g. Paget´s disease, osteoporosis)

• Male subjects of reproductive age who are not using a highly effective physical barrier method of contraception (sexual abstinence, or condom with spermicidal foam/gel/film/cream) combined with a method with Pearl Index less than 1% for their nonpregnant partner(s) (such as implants, injectables, combined oral contraceptives, hormonal intrauterine devices or diaphragm+spermicide, or surgical sterilisation or post-menopausal) and/or who intend to donate sperm in the period from start of Visit 2 up to 3 months following the administration of the investigational medicinal product

Related Conditions & MeSH terms

• Metabolism and Nutrition Disorder
• Nutrition Disorders
• Obesity
• Overweight

Intervention

Drug:
• NNC0174-0833
Subjects will receive a single s.c. (subcutaneous/under the skin) dose of NNC0174-0833. Up to nine dose levels of single s.c. doses of NNC0174-0833 are planned to be investigated.
• placebo
Subjects will receive a single s.c. (subcutaneousl/under the skin) dose.

Locations

Country	Name	City	State
United States	Novo Nordisk Investigational Site	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of treatment emergent adverse events (TEAEs)		From the time of dosing (Day 1) until completion of the post treatment follow-up visit (Day 43-50)
Secondary	Area under the NNC0174-0833 plasma concentration-time curve		Prior to the initial dose on day 1 and 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 48, 60, 72, 96, 120, 168, 240, 336, 504, and 1008 hours post-dose
Secondary	Maximum concentration of NNC0174-0833 in plasma		Prior to the initial dose on day 1 and 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 48, 60, 72, 96, 120, 168, 240, 336, 504, and 1008 hours post-dose
Secondary	Time to maximum concentration of NNC0174-0833 in plasma		Prior to the initial dose on day 1 and 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 48, 60, 72, 96, 120, 168, 240, 336, 504, and 1008 hours post-dose

External Links

•   Clinical Trials at Novo Nordisk