Rekovelle PK Trial in Chinese Women

NCT04150861 | Completed Phase 1 Results

• 1 other identifier: 000152
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

In vitro fertilisation; Controlled ovarian stimulation

Outcome Measures

Primary Outcomes (7)

• Area Under the Serum Concentration-time Curve From Dosing to Infinity (AUC)

  Area under the concentration-time curve from dosing to infinity.

  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.

  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.

  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.

  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)

  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)

  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)

  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)

  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

  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

  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

  From signed informed consent until the end-of-trial visit (Day 28)

• Frequency of Injection Site Reactions

  Immediately, 30 minutes, and 24 hours after administration

Study Arms (3)

Follitropin delta 12 μg

EXPERIMENTAL

Participants received single subcutaneous abdominal injection of Follitropin delta 12 μg on Day 1.

Drug: Follitropin Delta

Follitropin delta 18 μg

EXPERIMENTAL

Participants received single subcutaneous abdominal injection of Follitropin delta 18 μg on Day 1.

Drug: Follitropin Delta

Follitropin delta 24 μg

EXPERIMENTAL

Participants received single subcutaneous abdominal injection of Follitropin delta 24 μg on Day 1.

Drug: Follitropin Delta

Interventions

Follitropin Delta DRUG

Solution for Injection, subcutaneous administration

Also known as: REKOVELLE, FE 999049

Follitropin delta 12 μg; Follitropin delta 18 μg; Follitropin delta 24 μg

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (1)

First Hospital Affiliated to Nanjing Medical University Jiangsu Province Hospital

Nanjing, China

Location

Related Publications (1)

• 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.

  PMID: 36478528 RESULT

MeSH Terms

Conditions

Infertility

Interventions

follitropin delta; FE 999049

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Results Point of Contact

• Title: Global Clinical Compliance
• Organization: Ferring Pharmaceuticals

DK0-Disclosure@ferring.com

-

Study Officials

• Global Clinical Compliance

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2019
• First Posted: November 5, 2019
• Study Start: June 23, 2019
• Primary Completion: November 28, 2019
• Study Completion: December 16, 2019
• Last Updated: February 14, 2023
• Results First Posted: December 24, 2020

Record last verified: 2020-01

Locations

CN (1)