Comparative Pharmacokinetics of AFOLIA and US Gonal-f® RFF Redi-ject After Single Subcutaneous Application

NCT ID: NCT02459418

Last Updated: 2018-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-07
• Study Completion Date: 2016-05-19

Brief Summary

Comparative PK study after single SC application of Afolia and the reference product (US Gonal-f®). Objective: To demonstrate equivalence within 80%-125% margin of the reference product for the area under the curve (AUC) of Afolia.

Detailed Description

To demonstrate equivalence within the 80% to 125% margin of the reference product for the baseline corrected area under the follicle-stimulating hormone (FSH) serum concentration-time curve from time zero to the last quantifiable concentration of AFOLIA compared to the reference product (United States [US] Gonal-f® RFF)

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Afolia - US Gonal-f® (Sequence A) Arm

During the Cross-Over Pharmacokinetic Phase, subjects will be randomly assigned to receive treatment sequence: (Sequence A): Single subcutaneous injection of 225IU Afolia on study day 1, followed by a single subcutaneous injection of 225IU US Gonal-f® on study day 27.

Group Type: EXPERIMENTAL

Afolia

Intervention Type: DRUG

During the Cross-Over Pharmacokinetic Phase, subjects will be randomly assigned to receive one of the following treatment sequences:

Sequence A: Single subcutaneous injection of 225IU Afolia on study day 1, followed by a single subcutaneous injection of 225IU US Gonal-f® on study day 27.

Sequence B: Single subcutaneous injection of 225IU US Gonal-f® on study day 1, followed by a single subcutaneous injection of 225IU Afolia on study day 27

US Gonal-f®

Intervention Type: DRUG

During the Cross-Over Pharmacokinetic Phase, subjects will be randomly assigned to receive one of the following treatment sequences:

Sequence A: Single subcutaneous injection of 225IU Afolia on study day 1, followed by a single subcutaneous injection of 225IU US Gonal-f® on study day 27.

Sequence B: Single subcutaneous injection of 225IU US Gonal-f® on study day 1, followed by a single subcutaneous injection of 225IU Afolia on study day 27

US Gonal-f® - Afolia (Sequence B) Arm:

During the Cross-Over Pharmacokinetic Phase, patients will be randomly assigned to receive treatment sequence (Sequence B): Single subcutaneous injection of 225IU US Gonal-f® on study day 1, followed by a single subcutaneous injection of 225IU Afolia on study day 27

Group Type: ACTIVE_COMPARATOR

Afolia

Intervention Type: DRUG

During the Cross-Over Pharmacokinetic Phase, subjects will be randomly assigned to receive one of the following treatment sequences:

Sequence A: Single subcutaneous injection of 225IU Afolia on study day 1, followed by a single subcutaneous injection of 225IU US Gonal-f® on study day 27.

Sequence B: Single subcutaneous injection of 225IU US Gonal-f® on study day 1, followed by a single subcutaneous injection of 225IU Afolia on study day 27

US Gonal-f®

Intervention Type: DRUG

During the Cross-Over Pharmacokinetic Phase, subjects will be randomly assigned to receive one of the following treatment sequences:

Sequence A: Single subcutaneous injection of 225IU Afolia on study day 1, followed by a single subcutaneous injection of 225IU US Gonal-f® on study day 27.

Sequence B: Single subcutaneous injection of 225IU US Gonal-f® on study day 1, followed by a single subcutaneous injection of 225IU Afolia on study day 27

Interventions

Afolia

During the Cross-Over Pharmacokinetic Phase, subjects will be randomly assigned to receive one of the following treatment sequences:

Sequence A: Single subcutaneous injection of 225IU Afolia on study day 1, followed by a single subcutaneous injection of 225IU US Gonal-f® on study day 27.

Sequence B: Single subcutaneous injection of 225IU US Gonal-f® on study day 1, followed by a single subcutaneous injection of 225IU Afolia on study day 27

Intervention Type: DRUG

US Gonal-f®

During the Cross-Over Pharmacokinetic Phase, subjects will be randomly assigned to receive one of the following treatment sequences:

Sequence A: Single subcutaneous injection of 225IU Afolia on study day 1, followed by a single subcutaneous injection of 225IU US Gonal-f® on study day 27.

Sequence B: Single subcutaneous injection of 225IU US Gonal-f® on study day 1, followed by a single subcutaneous injection of 225IU Afolia on study day 27

Intervention Type: DRUG

Other Intervention Names

Follitropin Alfa; Follitropin Alfa

Eligibility Criteria

Inclusion Criteria

1. Healthy female volunteers aged 18 to 42 years (inclusive) with a Body mass index of 18.0 to 32.0 kg/m2 (inclusive)

2. Subjects who have used oral contraceptives for at least 3 months before study entry and are prepared to stop taking oral contraception from screening and to use effective non-hormonal methods of birth control until completion of 1 menstrual cycle after the last dose administration

3. Women of child bearing potential must agree to use effective non-hormonal contraception for birth control until completion of 1 menstrual cycle after the last dose administration

4. Subjects with a regular menstruation cycle (25 to 34 days) before initiation of oral contraception

5. Subjects with both ovaries

6. Subjects who are negative for drugs of abuse and alcohol tests at screening and each admission

7. Subjects who are healthy as determined by pre study medical history, physical examination and 12-Lead electrocardiogram (ECG)

8. Subjects whose clinical laboratory test results are not clinically relevant and are acceptable to the investigator

9. Subjects who are able and willing to give written informed consent

2. Subjects with polycystic ovary syndrome

3. Subjects with developing follicles or solid ovarian cysts >2 cm or complex cysts regardless of size

4. Subjects with a history of hypersensitivity to FSH (Ovary Hyperstimulation Syndrome)

5. Subjects with impaired thyroid function (treated or untreated)

6. Subjects with a history of malignant disease

7. Subjects with aspartate aminotransferase and/or alanine aminotransferase >2 x upper limit of normal reference range

8. Subjects with other clinically relevant findings (ECG, blood pressure, physical, laboratory examination)

9. Subjects with a smoking history of more than 5 cigarettes per day

10. Subjects with evidence of abuse of drugs or alcoholic beverages

11. Subjects with a positive screen for hepatitis B surface antigen, antibodies to the hepatitis C virus or antibodies to the human immunodeficiency virus 1/2

12. Subjects who have participated in a clinical trial within the 3 months prior to this study

13. Subjects who are unlikely to co-operate with the requirements of the study

14. Subjects with symptoms of a clinically relevant illness during the 3 weeks prior to study day -1

15. Subjects who are pregnant, lactating or attempting to become pregnant

16. Subjects with any medical condition (including a known predisposition to porphyria) that, in the opinion of the investigator, could interfere with safety of the subject or interfere with the objectives of the study

17. Subjects who are vegans or have medical dietary restrictions

18. Subjects who cannot communicate reliably with the investigator

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Fertility Biotech AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julian Jenkins, DM FRCOG

Role: STUDY_DIRECTOR

Fertility Biotech AG

Locations

Quintiles Drug Research Unit at Guy's Hospital

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

FIN1002

Identifier Type: -

Identifier Source: org_study_id