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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) of Somatropin [Срок оценки: 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 [Срок оценки: 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]

Вторичные конечные точки (4)

• Number of Participants With Treatment Emergent Adverse Events [Срок оценки: 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 [Срок оценки: Up to Day 11]
• Area under the effect-time curve from 0 to time of last measurable concentration (AUEClast) [Срок оценки: At pre-dose and 6, 12, 24, 48, 72 and 96 hours post-dose on day 1 of each period]
• Maximum observed effect (Emax) [Срок оценки: At pre-dose and 6, 12, 24, 48, 72 and 96 hours post-dose on day 1 of each period]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Бельгия · 1 центр

• Pfizer Clinical Research Unit - Brussels — Brussels

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗