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| ID | Type | Description | Link |
|---|---|---|---|
| 2026-525165-52-00 | Registry Identifier | CTIS (EU) |
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The purpose of this clinical study is to learn about how different injector pens affect:
The study is seeking participants who are:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | Single dose of 4 milligrams (mg) subcutaneous genotropin via marketed genotropin pen 12 (Reference) followed by single dose of 4mg subcutaneous genotropin via new genotropin injector pen (Test) |
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| Sequence 2 | Experimental | Single dose of 4mg subcutaneous genotropin via new genotropin injector pen (Test) followed by single dose of 4mg subcutaneous genotropin via marketed genotropin pen 12 (Reference) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Marketed Genotropin Pen 12 | Device | Growth Hormone Delivery Device for use with Somatropin for injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) of Somatropin | AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf). | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events | 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 | Up to Day 11 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Clinical Research Unit - Brussels | Recruiting | Brussels | Bruxelles-capitale, Région de | B-1070 | Belgium |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| New Genotropin Injector Pen | Device | Growth Hormone Delivery Device for use with Somatropin for injection |
|
| Genotropin 4mg | Drug | 4mg subcutaneous |
|
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| Area under the effect-time curve from 0 to time of last measurable concentration (AUEClast) | Area under the effect-time curve to the last observed time point of Serum IGF-1 | At pre-dose and 6, 12, 24, 48, 72 and 96 hours post-dose on day 1 of each period |
| Maximum observed effect (Emax) | Maximum observed effect of Serum IGF-1 | At pre-dose and 6, 12, 24, 48, 72 and 96 hours post-dose on day 1 of each period |
| ID | Term |
|---|---|
| D019382 | Human Growth Hormone |
| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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