Clinical trial NCT02592031: Study to Compare the Bioavailability, Safety and Tolerability of XM17 in Healthy, Down Regulated Young Women
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bioequivalence
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2015-10-30
Enrollment: 49
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Comparison of single dose pharmacokinetics (Cmax)
timeFrame: 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
measure: Comparison of single dose pharmacokinetics (AUC0-t)
timeFrame: 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
Secondary outcomes:
measure: Pharmacokinetics AUC0-∞
timeFrame: 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
measure: Pharmacokinetics AUC0-168h
timeFrame: 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
measure: Pharmacokinetics Cmax,obs
timeFrame: 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
measure: Pharmacokinetics Tmax
timeFrame: 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
measure: Pharmacokinetics λZ
timeFrame: 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
measure: Pharmacokinetics t1/2
timeFrame: 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
measure: Pharmacokinetics CL/F
timeFrame: 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
measure: Pharmacokinetics Vz/F
timeFrame: 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
measure: Percentage of participants with adverse events
timeFrame: Signing of informed consent to final data collection (27 days)
Other outcomes:
Locations:
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References:
citation: Lammerich A, Mueller A, Bias P. Phase I, two-way, crossover study to demonstrate bioequivalence and to compare safety and tolerability of single-dose XM17 vs Gonal-f(R) in healthy women after follicle-stimulating hormone downregulation. Reprod Biol Endocrinol. 2015 Dec 1;13:130. doi: 10.1186/s12958-015-0124-y.