How two different injector pens affect delivery of Genotropin (somatropin) in healthy adults
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
We will test whether two different injector pens deliver Genotropin (somatropin) differently into the blood of healthy adults aged 18 to 60.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 26 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Pfizer Industry-sponsored |
| Locations | 1 site (Brussels, Bruxelles-capitale, Région de) |
| Trial ID | NCT07542886 on ClinicalTrials.gov |
What this trial studies
This Phase 1, single-dose pharmacokinetic comparison gives healthy adult participants subcutaneous injections of Genotropin using two different injector pens and collects blood samples before and after dosing to measure somatropin concentrations. The measured blood levels from the two pens will be compared to see if delivery or uptake differs. Eligible participants are healthy men or women aged 18–60 with BMI 16–32 and body weight over 45 kg and must meet screening medical criteria. The total participation time is about 10 weeks including screening and dosing visits at the study site.
Who should consider this trial
Good fit: Healthy adults aged 18–60 with BMI 16–32 and body weight over 45 kg, no prior growth hormone exposure, and no significant medical conditions are the intended participants.
Not a fit: People who require therapeutic growth hormone treatment, have prior exposure to growth hormone, significant medical conditions, or cannot stop prohibited medications are unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, this could show the new injector pen delivers Genotropin similarly to the marketed pen, supporting interchangeable use and potentially improving convenience for people who use injectable growth hormone.
How similar studies have performed: Pharmacokinetic comparisons of growth hormone formulations and delivery devices have been performed previously and have commonly been able to show comparable blood levels between devices.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Brussels, Bruxelles-capitale, Région de
- Pfizer Clinical Research Unit - Brussels — Brussels, Bruxelles-capitale, Région de, Belgium (Recruiting)
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.