- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04150861
Rekovelle PK Trial in Chinese Women
February 13, 2023 updated by: Ferring Pharmaceuticals
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Nanjing, China
- First Hospital Affiliated to Nanjing Medical University Jiangsu Province Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 40 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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)
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Follitropin delta 12 μg
Participants received single subcutaneous abdominal injection of Follitropin delta 12 μg on Day 1.
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Solution for Injection, subcutaneous administration
Other Names:
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EXPERIMENTAL: Follitropin delta 18 μg
Participants received single subcutaneous abdominal injection of Follitropin delta 18 μg on Day 1.
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Solution for Injection, subcutaneous administration
Other Names:
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EXPERIMENTAL: Follitropin delta 24 μg
Participants received single subcutaneous abdominal injection of Follitropin delta 24 μg on Day 1.
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Solution for Injection, subcutaneous administration
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Area under the concentration-time curve from dosing to infinity.
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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
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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
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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.
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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
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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
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Maximum concentration observed in serum.
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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
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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
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Time of maximum observed concentration in serum.
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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
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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
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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
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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
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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
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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
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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Number of participants with clinically significant abnormal changes in ECG are presented.
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At screening, on Day -1, at 12, 24, 48 hours postdose, and at the follow-up visit (Day 11)
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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)
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Number of participants with clinically significant abnormal changes in vital signs (systemic blood pressures, heart rate and body temperature) are presented.
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At screening, on Day -1, at 12, 24, 48 hours postdose, and at the follow-up visit (Day 11)
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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)
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Number of participants with clinically significant abnormal findings in laboratory parameters (clinical chemistry, haematology, urinalysis) are presented.
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At screening, on Day -1 and Day 3, and at the follow-up visit (Day 11)
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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)
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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.
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From signed informed consent until the end-of-trial visit (Day 28)
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Frequency of Injection Site Reactions
Time Frame: Immediately, 30 minutes, and 24 hours after administration
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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.
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Immediately, 30 minutes, and 24 hours after administration
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Number of Participants With Treatment-induced Anti-follicle-stimulating Hormone (Anti-FSH) Antibodies
Time Frame: On Day 1 predose, Day 7, and Day 28
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On Day 1 predose, Day 7, and Day 28
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 23, 2019
Primary Completion (ACTUAL)
November 28, 2019
Study Completion (ACTUAL)
December 16, 2019
Study Registration Dates
First Submitted
November 1, 2019
First Submitted That Met QC Criteria
November 1, 2019
First Posted (ACTUAL)
November 5, 2019
Study Record Updates
Last Update Posted (ESTIMATE)
February 14, 2023
Last Update Submitted That Met QC Criteria
February 13, 2023
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 000152
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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