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

• Sponsor: Merckle GmbH (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02592031
• Collaborator: (none)
• Enrollment: 49
• Arms: 3
• Duration (Months): 10

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bioequivalence	Drug: XM17; Drug: Gonal-f®; Drug: Zoladex®	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 49 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Feb 1, 2009
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: XM17 XM17 will be administered by 1 mL syringes in graduated steps of 0.01 mL.	Drug: XM17; 300 IU corresponds to an injection volume of 0.5 mL.
Experimental: Gonal-f® Gonal-f® will be provided in pens with integrated vials of 0.5 mL	Drug: Gonal-f®; 300 IU corresponds to an injection volume of 0.5 mL.; Other Names: follitropin alfa
Active Comparator: Zoladex® Zoladex® 3.6 mg will be administered by subcutaneous injection	Drug: Zoladex®; 3.6 mg; Other Names: goserelin acetate

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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

1. 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

2. 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

3. 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

4. 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

5. 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.

6. 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.

7. 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

8. 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

9. Percentage of participants with adverse events [Signing of informed consent to final data collection (27 days)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 39 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Merckle GmbH

Investigators

• Study Director: Teva Medical Expert, MD, Teva Branded Pharmaceutical Products R&D, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Merckle GmbH
• ClinicalTrials.gov Identifier: NCT02592031
• Other Study ID Numbers: XM17-02; 2008-005756-24
• First Posted: Oct 30, 2015
• Last Update Posted: Nov 9, 2021
• Last Verified: Nov 1, 2021

• Additional relevant MeSH terms: Goserelin

Study Results

No Results Posted as of Nov 9, 2021