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

Bioequivalence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02592031
• Other study ID #: XM17-02
• Secondary ID: 2008-005756-24
• Status: Completed
• Phase: Phase 1
• Start date: February 2009
• Est. completion date: December 2009

Study information

• Verified date: November 2021
• Source: Teva Branded Pharmaceutical Products R&D, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: December 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Bioequivalence

Intervention

Drug:
• XM17
300 IU corresponds to an injection volume of 0.5 mL.
• Gonal-f®
300 IU corresponds to an injection volume of 0.5 mL.
• Zoladex®
3.6 mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merckle GmbH

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of single dose pharmacokinetics (Cmax)	XM17 and Gonal-f® tested statistically for bioequivalence.	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
Primary	Comparison of single dose pharmacokinetics (AUC0-t)	XM17 and Gonal-f® tested statistically for bioequivalence.	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	Pharmacokinetics AUC0-8	Area under the XM17 / Gonal-f® concentration time curve from time 0 extrapolated to infinity	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	Pharmacokinetics AUC0-168h	Area under the XM17 / Gonal-f® concentration time curve from time 0 to 168 h	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	Pharmacokinetics Cmax,obs	Maximum XM17 / Gonal-f® concentration determined during the interval of sample taking	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	Pharmacokinetics Tmax	Time to maximum XM17 / Gonal-f® concentration	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	Pharmacokinetics ?Z	Apparent terminal elimination rate constant.	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	Pharmacokinetics t1/2	Apparent terminal elimination half life.	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	Pharmacokinetics CL/F	Serum clearance after dosing	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	Pharmacokinetics Vz/F	Volume of Distribution during the terminal phase after extravascular administration	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	Percentage of participants with adverse events		Signing of informed consent to final data collection (27 days)