An open label, two period crossover study to explore the safety, pharmacokinetics and pharmacodynamics of PHA-794428 after single subcutaneous injections in adult male patients with growth hormone deficiency.
- Conditions
- AGHD Adult Growth Hormone Deficiency
- Registration Number
- EUCTR2005-001658-25-BE
- Lead Sponsor
- Pfizer Global Research and Development
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 8
Inclusion Criteria
Adult male patients with severe GHD aged 25 to 60 years.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Subjects who on direct questioning and physical examination have evidence of any clinically significant disease other than hypopituitarism. Hypopituitary patients must be on adequate hormone replacement therapy.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To explore the pharmacokinetics and pharmacodynamics of PHA-794428 after single subcutaneous injections in AGHD patients in order to support the development of a PK/PD model in this patient population.<br>To explore the safety, tolerance and humoral response of PHA-794428 after single subcutaneous injections in AGHD patients.<br>;Secondary Objective: ;Primary end point(s): Safety and tolerance of a single subcutaneous injection of PHA-794428: Monitoring of AE, safety lab, vital signs, physical examination, body temperature, ECG, signs of fluid retention (body weight, ring size measurement), reactions at the injection site (Draize scoring and Gracely Box scale)·Pharmacodynamic effects of PHA-794428 on IGF-1· PHA-794428 pharmacokinetics (AUC, Cmax, Tmax, T1/2) after single subcutaneous injection
- Secondary Outcome Measures
Name Time Method