InfertilityPhase 1NCT04150861
Rekovelle PK Trial in Chinese Women
A Phase 1 study testing Follitropin Delta in people with Infertility, run by Ferring Pharmaceuticals at 1 site in China.
Trial summary
FE 999049 is a gonadotropin preparation containing recombinant human follicle stimulating hormone (rhFSH) under development by Ferring Pharmaceuticals. It is intended for controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART) such as in… Read more about this study
- Who is it for?
- Ages 21 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Follitropin Delta
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 23 Jun 2019to 16 Dec 2019
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female of Chinese origin, with two ethnic Chinese parents and four ethnic Chinese grandparents 21-40 years of age (both inclusive)
- Willing to stop using combined oral contraceptives (COC) in relation to the first DECAPEPTYL Depot administration on Day -28
- Agrees to use a double barrier method of contraception between Day -63 and Day 28, if not abstinent. A double barrier method of contraception should also be used after Day 28 until menses resumes or until another contraceptive method has been established
- Normal menstrual cycles with a range of 24-35 days in the absence of oral contraceptives
- Serum FSH less than equal to (≤)5 IU/L on Day -3 and Day -1
- Body mass index (BMI) of 18.5 -25 kg/m^2 (both inclusive)
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- Negative serology for human immunodeficiency virus (HIV) antibody, hepatitis B (surface antigen), hepatitis C antibody, and syphilis bacteria
- Healthy according to medical history, physical examination, gynaecological examination, ECG, blood pressure, and laboratory profile of blood and urine
- Negative urine drug screen and alcohol breath test at screening and on Day -1
- Non-smoker or light smoker (≤ 5 cigarettes/day) for at least 6 months prior to trial
Who cannot join
- Presence or a history of clinically significant diseases of the renal, hepatic, gastrointestinal, cardiovascular, or musculoskeletal systems, or presence or history of clinically significant reproductive, psychiatric, immunological, endocrine or metabolic diseases
- Cancer within the last 5 years except for adequately managed basal cell carcinoma and squamous cell carcinoma of the skin
- Pregnancy or breastfeeding
- Current or a history of endocrine abnormalities such as hyperprolactinaemia, polycystic ovary syndrome or other ovarian dysfunction, tumours of the pituitary gland or hypothalamus, thyroid or adrenal disease
- Clinically significant findings on the trans-vaginal ultrasound, cytology, gynaecological or breast examination at screening or on Day -1 including ovarian cysts or tumours of the ovaries or uterus
- Contraindications for the use of gonadotropins and gonadotropin-releasing hormone (GnRH) agonists
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- Previously treated with gonadotropins within the last 6 months prior to screening
- History within the last two years or current abuse of alcohol or drugs
- Presence or history of severe allergy or anaphylactic reactions
- Intake of prescribed medication, over-the-counter (OTC) medication, or herbal medicines, with the exceptions of COC, cromoglycate, and paracetamol according to the labelling, within 2 weeks or 5 half-lives of the drug, whichever is longer, prior to first dose of DECAPEPTYL Depot. Topical treatments of bacterial or fungal infection are allowed if stopped before first dose of IMP
- Intake of any non-registered investigational drug within the last 12 weeks preceding screening, or longer if judged by the investigator to possibly influence the outcome of the current trial
- High daily consumption of caffeine-containing beverages (e.g. more than five cups of coffee or equivalent) with a risk of withdrawal symptoms arising during the trial that may confound the safety evaluation
- Blood donation or major blood loss (greater than equal to [≥]500 mL) within the last 8 weeks, or plasma donation with the last 4 weeks preceding the first day of IMP dosing
- Current non-smokers or light smoker with a history of long-term, heavy smoking (>10 pack-years)
- Previously dosed in this trial
- Mental incapacity or language barrier precluding adequate understanding or co-operation
- Considered by the investigator to be unsuitable to participate in the trial for any other reason
Trial locations and contacts
1 site in 1 country.
China1 site
First Hospital Affiliated to Nanjing Medical University Jiangsu Province Hospital
Nanjing
About this study
Official title: An Open-label Trial Investigating the Pharmacokinetics of FE 999049 Given as a Single Subcutaneous Dose in Gonadotropin Down-regulated Healthy Chinese Women
FE 999049 is a gonadotropin preparation containing recombinant human follicle stimulating hormone (rhFSH) under development by Ferring Pharmaceuticals. It is intended for controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART) such as in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle. In previous trials the exposure to and dose proportionality of FE 999049 in a clinically relevant dose range in Caucasian and Japanese healthy women have been shown to be very similar. This is a trial in healthy Chinese women investigating the pharmacokinetics, safety, and tolerability of a single subcutaneous dose of FE 999049.
- Conditions
- Infertility
- Being tested
- Follitropin Delta
- Keywords
- In vitro fertilisation, Controlled ovarian stimulation
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follitropin DeltaDrug
Also called REKOVELLE, FE 999049
Solution for Injection, subcutaneous administration
| Study group | Role | What they receive |
|---|---|---|
| Follitropin delta 12 μg | Experimental | Participants received single subcutaneous abdominal injection of Follitropin delta 12 μg on Day 1. Receives: Drug: Follitropin Delta |
| Follitropin delta 18 μg | Experimental | Participants received single subcutaneous abdominal injection of Follitropin delta 18 μg on Day 1. Receives: Drug: Follitropin Delta |
| Follitropin delta 24 μg | Experimental | Participants received single subcutaneous abdominal injection of Follitropin delta 24 μg on Day 1. Receives: Drug: Follitropin Delta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Serum Concentration-time Curve From Dosing to Infinity (AUC)
Area under the concentration-time curve from dosing to infinity.
Measured: At -1, -0.5 and 0 hour predose, and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48 hours, and 3, 4, 5, 6, 7, 8, and 9 days postdose
Area Under the Serum Concentration-time Curve From Dosing up to Time t (AUCt)
AUCt is defined as the area under the serum concentration-time curve from dosing up to time t, where t is the last time point at which the concentration is above the lower limit of quantification.
Measured: At -1, -0.5 and 0 hour predose, and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48 hours, and 3, 4, 5, 6, 7, 8, and 9 days postdose
Maximum Serum Concentration Observed (Cmax)
Maximum concentration observed in serum.
Measured: At -1, -0.5 and 0 hour predose, and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48 hours, and 3, 4, 5, 6, 7, 8, and 9 days postdose
Time of Maximum Observed Serum Concentration (Tmax)
Time of maximum observed concentration in serum.
Measured: At -1, -0.5 and 0 hour predose, and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48 hours, and 3, 4, 5, 6, 7, 8, and 9 days postdose
Apparent Total Systemic Clearance (CL/F)
Measured: At -1, -0.5 and 0 hour predose, and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48 hours, and 3, 4, 5, 6, 7, 8, and 9 days postdose
Apparent Volume of Distribution Associated With the Terminal Phase (VZ/F)
Measured: At -1, -0.5 and 0 hour predose, and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48 hours, and 3, 4, 5, 6, 7, 8, and 9 days postdose
Terminal Elimination Half-life (t½)
Measured: At -1, -0.5 and 0 hour predose, and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48 hours, and 3, 4, 5, 6, 7, 8, and 9 days postdose
Secondary outcomes (6)
Number of Participants With Clinically Significant Abnormal Changes in Electrocardiogram (ECG)
Number of participants with clinically significant abnormal changes in ECG are presented.
Measured: At screening, on Day -1, at 12, 24, 48 hours postdose, and at the follow-up visit (Day 11)
Number of Participants With Clinically Significant Abnormal Changes in Vital Signs
Number of participants with clinically significant abnormal changes in vital signs (systemic blood pressures, heart rate and body temperature) are presented.
Measured: At screening, on Day -1, at 12, 24, 48 hours postdose, and at the follow-up visit (Day 11)
Number of Participants With Clinically Significant Abnormal Findings in Laboratory Parameters
Number of participants with clinically significant abnormal findings in laboratory parameters (clinical chemistry, haematology, urinalysis) are presented.
Measured: At screening, on Day -1 and Day 3, and at the follow-up visit (Day 11)
Number of Participants With Adverse Events (AEs) and Type of AEs
An AE is any untoward medical occurrence in a participant participating in a clinical trial. Number of participants with any AE (serious or non-serious) and type of AEs ( mild, moderate, severe) are presented.
Measured: From signed informed consent until the end-of-trial visit (Day 28)
Frequency of Injection Site Reactions
The injection site reactions (redness, pain, itching, swelling, and bruising) will be assessed by the investigator after injection, 30 minutes, and 24 hours after administration of the IMP. Each injection site reaction will be assessed as none, mild, moderate, or severe.
Measured: Immediately, 30 minutes, and 24 hours after administration
Number of Participants With Treatment-induced Anti-follicle-stimulating Hormone (Anti-FSH) Antibodies
Measured: On Day 1 predose, Day 7, and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start23 Jun 2019
- Primary completion28 Nov 2019
- Study completion16 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Compliance, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04150861
- Sponsor's protocol ID
- 000152
- Status last verified
- Jan 2020
- First submitted
- 1 Nov 2019
- Last updated
- 14 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shao F, Jiang Y, Ding S, Larsson P, Pinton P, Jonker DM. Pharmacokinetics and Safety of Follitropin Delta in Gonadotropin Down-Regulated Healthy Chinese Women. Clin Drug Investig. 2023 Jan;43(1):37-44. doi: 10.1007/s40261-022-01232-9. Epub 2022 Dec 7.
PubMed 36478528
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Trial Investigating the Pharmacokinetics of FE 999049 Given as a Single Subcutaneous Dose in Gonadotropin Down-regulated Healthy Chinese Women
- ClinicalTrials.gov ID
- NCT04150861
- Acronym / sponsor ID
- 000152
- Conditions
- Infertility
- Keywords
- In vitro fertilisation, Controlled ovarian stimulation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 23 Jun 2019 (actual)
- Primary completion
- 28 Nov 2019 (actual)
- Study completion
- 16 Dec 2019 (actual)
- First posted
- 5 Nov 2019 (actual)
- Results
- Posted 24 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
FE 999049 is a gonadotropin preparation containing recombinant human follicle stimulating hormone (rhFSH) under development by Ferring Pharmaceuticals. It is intended for controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART) such as in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle. In previous trials the exposure to and dose proportionality of FE 999049 in a clinically relevant dose range in Caucasian and Japanese healthy women have been shown to be very similar. This is a trial in healthy Chinese women investigating the pharmacokinetics, safety, and tolerability of a single subcutaneous dose of FE 999049.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Follitropin delta 12 μg | Experimental | Drug: Follitropin DeltaParticipants received single subcutaneous abdominal injection of Follitropin delta 12 μg on Day 1. |
| Follitropin delta 18 μg | Experimental | Drug: Follitropin DeltaParticipants received single subcutaneous abdominal injection of Follitropin delta 18 μg on Day 1. |
| Follitropin delta 24 μg | Experimental | Drug: Follitropin DeltaParticipants received single subcutaneous abdominal injection of Follitropin delta 24 μg on Day 1. |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Female of Chinese origin, with two ethnic Chinese parents and four ethnic Chinese grandparents 21-40 years of age (both inclusive)
- Willing to stop using combined oral contraceptives (COC) in relation to the first DECAPEPTYL Depot administration on Day -28
- Agrees to use a double barrier method of contraception between Day -63 and Day 28, if not abstinent. A double barrier method of contraception should also be used after Day 28 until menses resumes or until another contraceptive method has been established
- Normal menstrual cycles with a range of 24-35 days in the absence of oral contraceptives
- Serum FSH less than equal to (≤)5 IU/L on Day -3 and Day -1
Key exclusion criteria (17 listed)
- Presence or a history of clinically significant diseases of the renal, hepatic, gastrointestinal, cardiovascular, or musculoskeletal systems, or presence or history of clinically significant reproductive, psychiatric, immunological, endocrine or metabolic diseases
- Cancer within the last 5 years except for adequately managed basal cell carcinoma and squamous cell carcinoma of the skin
- Pregnancy or breastfeeding
- Current or a history of endocrine abnormalities such as hyperprolactinaemia, polycystic ovary syndrome or other ovarian dysfunction, tumours of the pituitary gland or hypothalamus, thyroid or adrenal disease
- Clinically significant findings on the trans-vaginal ultrasound, cytology, gynaecological or breast examination at screening or on Day -1 including ovarian cysts or tumours of the ovaries or uterus
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 |
|---|---|---|
| Follitropin DeltaAlso: REKOVELLE, FE 999049Solution for Injection, subcutaneous administration | Drug | Follitropin delta 12 μg, Follitropin delta 18 μg, Follitropin delta 24 μg |
Primary outcome
Area Under the Serum Concentration-time Curve From Dosing to Infinity (AUC)
Time frame: At -1, -0.5 and 0 hour predose, and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48 hours, and 3, 4, 5, 6, 7, 8, and 9 days postdose
Area under the concentration-time curve from dosing to infinity.
Area Under the Serum Concentration-time Curve From Dosing up to Time t (AUCt)
Time frame: At -1, -0.5 and 0 hour predose, and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48 hours, and 3, 4, 5, 6, 7, 8, and 9 days postdose
AUCt is defined as the area under the serum concentration-time curve from dosing up to time t, where t is the last time point at which the concentration is above the lower limit of quantification.
Maximum Serum Concentration Observed (Cmax)
Time frame: At -1, -0.5 and 0 hour predose, and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48 hours, and 3, 4, 5, 6, 7, 8, and 9 days postdose
Maximum concentration observed in serum.
Time of Maximum Observed Serum Concentration (Tmax)
Time frame: At -1, -0.5 and 0 hour predose, and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48 hours, and 3, 4, 5, 6, 7, 8, and 9 days postdose
Time of maximum observed concentration in serum.
Apparent Total Systemic Clearance (CL/F)
Time frame: At -1, -0.5 and 0 hour predose, and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48 hours, and 3, 4, 5, 6, 7, 8, and 9 days postdose
Apparent Volume of Distribution Associated With the Terminal Phase (VZ/F)
Time frame: At -1, -0.5 and 0 hour predose, and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48 hours, and 3, 4, 5, 6, 7, 8, and 9 days postdose
Terminal Elimination Half-life (t½)
Time frame: At -1, -0.5 and 0 hour predose, and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48 hours, and 3, 4, 5, 6, 7, 8, and 9 days postdose
6 secondary outcomes
Number of Participants With Clinically Significant Abnormal Changes in Electrocardiogram (ECG)
Time frame: At screening, on Day -1, at 12, 24, 48 hours postdose, and at the follow-up visit (Day 11)
Number of Participants With Clinically Significant Abnormal Changes in Vital Signs
Time frame: At screening, on Day -1, at 12, 24, 48 hours postdose, and at the follow-up visit (Day 11)
Number of Participants With Clinically Significant Abnormal Findings in Laboratory Parameters
Time frame: At screening, on Day -1 and Day 3, and at the follow-up visit (Day 11)
Number of Participants With Adverse Events (AEs) and Type of AEs
Time frame: From signed informed consent until the end-of-trial visit (Day 28)
Frequency of Injection Site Reactions
Time frame: Immediately, 30 minutes, and 24 hours after administration
Number of Participants With Treatment-induced Anti-follicle-stimulating Hormone (Anti-FSH) Antibodies
Time frame: On Day 1 predose, Day 7, and Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 36478528Shao F, Jiang Y, Ding S, Larsson P, Pinton P, Jonker DM. Pharmacokinetics and Safety of Follitropin Delta in Gonadotropin Down-Regulated Healthy Chinese Women. Clin Drug Investig. 2023 Jan;43(1):37-44. doi: 10.1007/s40261-022-01232-9. Epub 2022 Dec 7.
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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.
Global Clinical Compliance study director
Ferring Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Follitropin Delta in people with Infertility, run by Ferring Pharmaceuticals at 1 site in China.
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 10 inclusion and 17 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 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 24 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Area Under the Serum Concentration-time Curve From Dosing to Infinity (AUC) (time frame: At -1, -0.5 and 0 hour predose, and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48 hours, and 3, 4, 5, 6, 7, 8, and 9 days postdose). The study lists 7 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 NCT04150861, 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 14 Feb 2023.