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Recruiting NCT07542886

A Study to Learn How Different Injector Pens Affect the Study Medicine Called Genotropin (Somatropin) Delivery and Taken up Into the Blood in Healthy Adults

Phase I Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Marketed Genotropin Pen 12, New Genotropin Injector Pen, Genotropin 4mg.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE-DOSE, CROSSOVER STUDY TO EVALUATE THE BIOEQUIVALENCE OF TWO DIFFERENT INJECTOR PEN DEVICES FOLLOWING SUBCUTANEOUS ADMINISTRATION OF THE SAME GENOTROPIN® (SOMATROPIN) DOSE IN HEALTHY ADULT PARTICIPANTS

Overview

The purpose of this clinical study is to learn about how different injector pens affect: * how the study medicine (called Genotropin) is delivered into the body and * how the study medicine is taken up into the blood in healthy adults. The study is seeking participants who are: * Aged 18 to 60 years old * Male or female who are healthy as determined by medical assessment * Body-mass index (BMI) of 16 to 32, and a total body weight more than 45 kg. BMI is a way to estimate a healthy body weight for an adult's height. Adults in this study will receive study medicine by a shot under the skin. The study medicine will be given using 2 different injector pens which are medical devices that give a shot under the skin. Blood samples will be taken before and after the shots to look for the study medicine. We will compare the amount of study medicine in the blood between shots from the 2 injector pens. Adults will take part in this study for about 10 weeks including the screening period. They will have to stay at the study clinic for at least 13 days. This includes 2 study periods in total. A follow up phone call will be made 23 to 30 days following the last study period.

Interventions

  • Device Marketed Genotropin Pen 12
    Growth Hormone Delivery Device for use with Somatropin for injection
  • Device New Genotropin Injector Pen
    Growth Hormone Delivery Device for use with Somatropin for injection
  • Drug Genotropin 4mg
    4mg subcutaneous

Primary outcome measures

  • Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) of Somatropin [Time frame: At pre-dose -24, -18, -12, -8, 0 and 1, 2, 3, 4, 6, 8, 10, 12, 16 and 24 hours post-dose on day 1 of each period]
  • Maximum Observed Plasma Concentration (Cmax) for Somatropin [Time frame: At pre-dose -24, -18, -12, -8, 0 and 1, 2, 3, 4, 6, 8, 10, 12, 16 and 24 hours post-dose on day 1 of each period]
Secondary outcome measures (4)
  • Number of Participants With Treatment Emergent Adverse Events [Time frame: From start of study treatment up to 28-35 days after last dose of study treatment (41 days)]
  • Number of Participants With Clinical Laboratory Abnormalities [Time frame: Up to Day 11]
  • Area under the effect-time curve from 0 to time of last measurable concentration (AUEClast) [Time frame: At pre-dose and 6, 12, 24, 48, 72 and 96 hours post-dose on day 1 of each period]
  • Maximum observed effect (Emax) [Time frame: At pre-dose and 6, 12, 24, 48, 72 and 96 hours post-dose on day 1 of each period]

Eligibility criteria

Inclusion criteria

  • Healthy Participants
  • BMI 16 to 32 kg/m2
  • body weight more than 45kg

Exclusion criteria

  • Ongoing or past history of significant medical conditions
  • Use of prescription or non prescription medications within 14 days of first study dose
  • Previous exposure to growth hormone
  • History of alcohol abuse, binge drinking or illicit drug use

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Basic science

Study locations

Belgium · 1 center
  • Pfizer Clinical Research Unit - Brussels — Brussels

Identifiers

NCT: NCT07542886 · A6281331 · 2026-525165-52-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗