Healthy
Conditions
Keywords
bioequivalence, genotropin, adult
Brief summary
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
DEVICEMarketed Genotropin Pen 12
Growth Hormone Delivery Device for use with Somatropin for injection
DEVICENew Genotropin Injector Pen
Growth Hormone Delivery Device for use with Somatropin for injection
DRUGGenotropin 4mg
4mg subcutaneous
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) of 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 | 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). |
| 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 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Area under the effect-time curve from 0 to time of last measurable concentration (AUEClast) | At pre-dose and 6, 12, 24, 48, 72 and 96 hours post-dose on day 1 of each period | Area under the effect-time curve to the last observed time point of Serum IGF-1 |
| Maximum observed effect (Emax) | At pre-dose and 6, 12, 24, 48, 72 and 96 hours post-dose on day 1 of each period | Maximum observed effect of Serum IGF-1 |
Countries
Belgium
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed