The purpose of the study is to investigate the effects of oxyntomodulin, a substance that is naturally produced in your body, when you fast (not eat for a period of time) and when you are given a glucose (sugar water) infusion.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
anti-obesity
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pharmacodynamics
Pharmacokinetics
Safety
Secondary outcome
N/A
Background summary
Study to assess Ketogenesis and Glucose-Dependent Insulin Secretion
Methodologies in Healthy Male Subjects
Study objective
The purpose of the study is to investigate the effects of oxyntomodulin, a
substance that is naturally produced in your body, when you fast (not eat for a
period of time) and when you are given a glucose (sugar water) infusion.
Study design
Procedures and assessments:
Screening and follow-up:
Clinical laboratory, bloodpressure and vital signs, physical examination,
12-lead ECG, drug screen
Only by screening:
medical history, height, weight, HBsAG, anti HCV and anti-HIV.
Observation period:
3 periods of -17 up to approx 9 hours after dosing
Study burden and risks
Procedures: pain, light bleeding, heamatoma and possibly an infection.
Whitehouse Station
NJ, 08889-0100
USA
Whitehouse Station
NJ, 08889-0100
USA
Listed location countries
Age
Inclusion criteria
18-45 years,
BMI 27-35 kg/m2 (inclusive)
Exclusion criteria
Suffering from: hepatitis B, cancer or HIV/Aids. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters blood in the 10 months preceding the start of the study.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL31991.056.10 |