BioequivalencePhase 1NCT02592031
Study to Compare the Bioavailability, Safety and Tolerability of XM17 in Healthy, Down Regulated Young Women
A Phase 1 study testing XM17, Gonal-f® and Zoladex® in people with Bioequivalence, run by Merckle GmbH.
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. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence
- What is being tested?
- XM17, Gonal-f® and Zoladex®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- Feb 2009to Dec 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
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.
- Conditions
- Bioequivalence
- Being tested
- XM17, Gonal-f®, Zoladex®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XM17Drug
300 IU corresponds to an injection volume of 0.5 mL.
Gonal-f®Drug
Also called follitropin alfa
300 IU corresponds to an injection volume of 0.5 mL.
Zoladex®Drug
Also called goserelin acetate
3.6 mg
| Study group | Role | What they receive |
|---|---|---|
| XM17 | Experimental | XM17 will be administered by 1 mL syringes in graduated steps of 0.01 mL. Receives: Drug: XM17 |
| Gonal-f® | Experimental | Gonal-f® will be provided in pens with integrated vials of 0.5 mL Receives: Drug: Gonal-f® |
| Zoladex® | Active comparator | Zoladex® 3.6 mg will be administered by subcutaneous injection Receives: Drug: Zoladex® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of single dose pharmacokinetics (Cmax)
XM17 and Gonal-f® tested statistically for bioequivalence.
Measured: 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
Comparison of single dose pharmacokinetics (AUC0-t)
XM17 and Gonal-f® tested statistically for bioequivalence.
Measured: 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 (9)
Pharmacokinetics AUC0-∞
Area under the XM17 / Gonal-f® concentration time curve from time 0 extrapolated to infinity
Measured: 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
Pharmacokinetics AUC0-168h
Area under the XM17 / Gonal-f® concentration time curve from time 0 to 168 h
Measured: 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
Pharmacokinetics Cmax,obs
Maximum XM17 / Gonal-f® concentration determined during the interval of sample taking
Measured: 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
Pharmacokinetics Tmax
Time to maximum XM17 / Gonal-f® concentration
Measured: 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
Pharmacokinetics λZ
Apparent terminal elimination rate constant.
Measured: 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
Pharmacokinetics t1/2
Apparent terminal elimination half life.
Measured: 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
Pharmacokinetics CL/F
Serum clearance after dosing
Measured: 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
Pharmacokinetics Vz/F
Volume of Distribution during the terminal phase after extravascular administration
Measured: 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
Percentage of participants with adverse events
Measured: Signing of informed consent to final data collection (27 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study startFeb 2009
- Primary completionMay 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BioequivalenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merckle GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Teva Medical Expert, MD, Study director, Teva Branded Pharmaceutical Products R&D, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02592031
- Sponsor's protocol ID
- XM17-02
- Other IDs
- 2008-005756-24, 2008
- Status last verified
- Nov 2021
- First submitted
- 28 Oct 2015
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26621118
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02592031
- Acronym / sponsor ID
- XM17-02
- Conditions
- Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Merckle GmbHIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- May 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 30 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| XM17 | Experimental | Drug: XM17XM17 will be administered by 1 mL syringes in graduated steps of 0.01 mL. |
| Gonal-f® | Experimental | Drug: Gonal-f®Gonal-f® will be provided in pens with integrated vials of 0.5 mL |
| Zoladex® | Active comparator | Drug: Zoladex®Zoladex® 3.6 mg will be administered by subcutaneous injection |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XM17300 IU corresponds to an injection volume of 0.5 mL. | Drug | XM17 |
| Gonal-f®Also: follitropin alfa300 IU corresponds to an injection volume of 0.5 mL. | Drug | Gonal-f® |
| Zoladex®Also: goserelin acetate3.6 mg | Drug | Zoladex® |
Primary outcome
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.
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.
9 secondary outcomes
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
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
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
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
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
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
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
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
Percentage of participants with adverse events
Time frame: Signing of informed consent to final data collection (27 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
- Derived from this study: PubMed 26621118Lammerich 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teva Medical Expert, MD study director
Teva Branded Pharmaceutical Products R&D, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing XM17, Gonal-f® and Zoladex® in people with Bioequivalence, run by Merckle GmbH.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02592031, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2021.