Objectives:Primary Objective: • To assess the safety and tolerability of single and multiple ascending doses of BIM23B065 when given as a subcutaneous (s.c.) bolus injection in young healthy male subjects.Secondary objectives:• To determine the…
ID
Source
Brief title
Condition
- Hypothalamus and pituitary gland disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety: Incidence and severity of adverse events, laboratory abnormalities,
changes in ECGs and Vital signs
Secondary outcome
Pharmacokinetic characteristics of BIM23B065 and pharmacodynamic markers
profile (Growth Hormone cycle, Prolactin cycle and Insulin like growth factor-1
levels).
Background summary
Acromegaly is a syndrome that is the result of an excess growth hormone
production in the anterior pituitary gland. The primary goal of treatment is to
reduce growth hormone production to normal levels. Current medical treatments
are somatostatin analogues and dopamine analogues, which both stop growth
hormone production in a different way. BIM23B065 is a drug substance, which
works on both dopamine and somatostatin mechanisms and therefore an attractive
candidate for the treatment of acromegaly.
Study objective
Objectives:
Primary Objective:
• To assess the safety and tolerability of single and multiple ascending doses
of BIM23B065 when given as a subcutaneous (s.c.) bolus injection in young
healthy male subjects.
Secondary objectives:
• To determine the maximal administrable dose of single and multiple ascending
doses of BIM23B065 when given as a s.c. bolus injection in young healthy male
subjects.
• To investigate the pharmacokinetic (PK) profile of single and multiple
ascending doses when given by s.c. bolus injection in young healthy male
subjects.
• To investigate the pharmacodynamic (PD) markers profile following single and
multiple ascending doses when given by s.c. bolus injection in young healthy
male subjects.
• To investigate the safety and PK profiles of different volumes of
administration during
the titration period.
Study design
The study will be a single-center, double-blind, randomized,
placebo-controlled, single ascending dose and multiple ascending dose study to
evaluate the safety, tolerability, PK and PD of BIM23B065 when given by s.c.
bolus injection in young healthy male subjects.
Intervention
Single or multiple doses of BIM23B065 or placebo.
Study burden and risks
Potential side effects of BIM23B065 injections and potential complaints caused
by being fasted, de lifestyle restrictions, the timeinvestments and blood
sample collection.
Zernikedreef 8
Leiden 2333CL
NL
Zernikedreef 8
Leiden 2333CL
NL
Listed location countries
Age
Inclusion criteria
- healthy male subjects
- 18-45 yrs, inclusive
- BMI: 19-30 kg/m2, inclusive
- Provision of written informed consent
Exclusion criteria
Any clinically significant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study. Positive test at screening of any of the following: Hepatitis B, Hepatitis C or human immunodeficiency virus/AIDS, History of cholelithiasis, or detected at screening gallbladder echography
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 |
|---|---|
| EudraCT | EUCTR2014-004561-24-NL |
| CCMO | NL52019.056.15 |