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Completed

NCT Number: NCT02592031

Study to Compare the Bioavailability, Safety and Tolerability of XM17 in Healthy, Down Regulated Young Women

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.

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Key information

Conditions

Bioequivalence

Age range

18 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

XM17

Drug

300 IU corresponds to an injection volume of 0.5 mL.

Gonal-F®

Drug

300 IU corresponds to an injection volume of 0.5 mL.

Other names: follitropin alfa

Zoladex®

Drug

3.6 mg

Other names: goserelin acetate

Primary outcomes

  1. Comparison of single dose pharmacokinetics (Cmax)

    Time frame: 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.

  2. Comparison of single dose pharmacokinetics (AUC0-t)

    Time frame: 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 outcomes

  1. Pharmacokinetics AUC0-∞

    Time frame: 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

  2. Pharmacokinetics AUC0-168h

    Time frame: 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

  3. Pharmacokinetics Cmax,obs

    Time frame: 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

  4. Pharmacokinetics Tmax

    Time frame: 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

  5. Pharmacokinetics λZ

    Time frame: 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.

  6. Pharmacokinetics t1/2

    Time frame: 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.

  7. Pharmacokinetics CL/F

    Time frame: 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

  8. Pharmacokinetics Vz/F

    Time frame: 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

  9. Percentage of participants with adverse events

    Time frame: Signing of informed consent to final data collection (27 days)

Sponsors and collaborators

Lead sponsor

Merckle GmbH

Industry

Registry information

Official study title

An Open, Randomized, Two-way Cross-over Phase I Study to Compare the Bioavailability, Safety and Tolerability of Single s.c. Doses of 300 IU XM17 With 300 IU Gonal-f® in 36 Healthy, Down-regulated Young Women

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Oct 30, 2015
Registry last updated
Nov 9, 2021

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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