FindTrial
Sign In

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.

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-001658-25-BE
Enrollment
8
Registered
2005-07-05
Start date
2005-06-16
Completion date
Unknown
Last updated
2014-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AGHD Adult Growth Hormone Deficiency

Interventions

Product Code: PHA-794428 Pharmaceutical Form: Powder for injection* Current Sponsor code: PHA-794428 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Product Cod

Sponsors

Pfizer Global Research and Development
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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. To explore the safety, tolerance and humoral response of PHA-794428 after single subcutaneous injections in AGHD patients. ;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—

Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026