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NCT Number: 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

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.

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Key information

Conditions

Healthy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Clinical Research Unit - Brussels

Brussels, Bruxelles-capitale, Région de, B-1070, Belgium

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Marketed Genotropin Pen 12

Device

Growth Hormone Delivery Device for use with Somatropin for injection

New Genotropin Injector Pen

Device

Growth Hormone Delivery Device for use with Somatropin for injection

Genotropin 4mg

Drug

4mg subcutaneous

Other names: Somatropin

Primary outcomes

  1. 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

    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).

  2. 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 outcomes

  1. 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)

  2. Number of Participants With Clinical Laboratory Abnormalities

    Time frame: Up to Day 11

  3. 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

    Area under the effect-time curve to the last observed time point of Serum IGF-1

  4. 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

    Maximum observed effect of Serum IGF-1

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 21, 2026
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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