Study to Compare the Bioavailability, Safety and Tolerability of XM17 in Healthy, Down Regulated Young Women
- Registration Number
- NCT02592031
- Lead Sponsor
- Merckle GmbH
- Brief Summary
Aim of this study is to demonstrate the bioequivalence of single subcutaneous doses of XM17 and Gonal-f® in a confirmatory design. Furthermore, safety and tolerability will be assessed in human healthy female subjects. Only female subjects will be included in the study to reach the objectives of the study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 49
- Having signed written informed consent
- Healthy female subjects of any racial origin
- 18-39 years at the time of screening
- Body mass index (BMI) between 18-29 kg/m2 and a body weight of ≥ 50 kg
- Use of oral contraceptives for contraceptive purposes only and not for regularization of menstrual cycle, for at least 3 months
- Normal uterus and two functioning ovaries
- Agrees to use an adequate method of contraception during the study
- Non-smoking or moderate smokers of < 10 cigarettes a day
- Pregnancy
- Polycystic ovary syndrome, impaired ovarian function, severe endometriosis class III or IV, submucosal myoma uteri
- History of endocrine abnormalities with treatment within the last six months.
- Contraindications for the use of gonadotropins and goserelin
- Breast-feeding or being within a period of 2 months after delivery or abortion.
- Use of an injectable hormonal contraceptive within a period of 6 months prior to screening
- Treatment in the previous three months with any drug known to have a well-defined potential for toxicity to a major organ
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description XM17 XM17 XM17 will be administered by 1 mL syringes in graduated steps of 0.01 mL. Gonal-f® Gonal-f® Gonal-f® will be provided in pens with integrated vials of 0.5 mL Zoladex® Zoladex® Zoladex® 3.6 mg will be administered by subcutaneous injection
- Primary Outcome Measures
Name Time Method Comparison of single dose pharmacokinetics (Cmax) Pre-dose at -10 min, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose XM17 and Gonal-f® tested statistically for bioequivalence.
Comparison of single dose pharmacokinetics (AUC0-t) Pre-dose at -10 min, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose XM17 and Gonal-f® tested statistically for bioequivalence.
- Secondary Outcome Measures
Name Time Method Pharmacokinetics AUC0-168h Pre-dose at -10 min, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose Area under the XM17 / Gonal-f® concentration time curve from time 0 to 168 h
Pharmacokinetics AUC0-∞ Pre-dose at -10 min, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose Area under the XM17 / Gonal-f® concentration time curve from time 0 extrapolated to infinity
Pharmacokinetics λZ Pre-dose at -10 min, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose Apparent terminal elimination rate constant.
Pharmacokinetics Cmax,obs Pre-dose at -10 min, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose Maximum XM17 / Gonal-f® concentration determined during the interval of sample taking
Pharmacokinetics Tmax Pre-dose at -10 min, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose Time to maximum XM17 / Gonal-f® concentration
Pharmacokinetics t1/2 Pre-dose at -10 min, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose Apparent terminal elimination half life.
Pharmacokinetics CL/F Pre-dose at -10 min, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose Serum clearance after dosing
Pharmacokinetics Vz/F Pre-dose at -10 min, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose Volume of Distribution during the terminal phase after extravascular administration
Percentage of participants with adverse events Signing of informed consent to final data collection (27 days)