Healthy VolunteersPhase 1NCT02459418

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

A Phase 1 study testing Afolia and US Gonal-f® in people with Healthy Volunteers, run by Fertility Biotech AG at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 42 years, women onlyHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Afolia and US Gonal-f®
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 1 siteUnited Kingdom
Study dates: 7 May 2015to 19 May 2016
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 18 to 42 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy female volunteers aged 18 to 42 years (inclusive) with a Body mass index of 18.0 to 32.0 kg/m2 (inclusive)
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
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
Subjects with a regular menstruation cycle (25 to 34 days) before initiation of oral contraception
Subjects with both ovaries
Subjects who are negative for drugs of abuse and alcohol tests at screening and each admission

Show all 9Show fewer

Subjects who are healthy as determined by pre study medical history, physical examination and 12-Lead electrocardiogram (ECG)
Subjects whose clinical laboratory test results are not clinically relevant and are acceptable to the investigator
Subjects who are able and willing to give written informed consent

Who cannot join

Subjects who do not conform to the above inclusion criteria
Subjects with polycystic ovary syndrome
Subjects with developing follicles or solid ovarian cysts >2 cm or complex cysts regardless of size
Subjects with a history of hypersensitivity to FSH (Ovary Hyperstimulation Syndrome)
Subjects with impaired thyroid function (treated or untreated)
Subjects with a history of malignant disease

Show all 18Show fewer

Subjects with aspartate aminotransferase and/or alanine aminotransferase >2 x upper limit of normal reference range
Subjects with other clinically relevant findings (ECG, blood pressure, physical, laboratory examination)
Subjects with a smoking history of more than 5 cigarettes per day
Subjects with evidence of abuse of drugs or alcoholic beverages
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
Subjects who have participated in a clinical trial within the 3 months prior to this study
Subjects who are unlikely to co-operate with the requirements of the study
Subjects with symptoms of a clinically relevant illness during the 3 weeks prior to study day -1
Subjects who are pregnant, lactating or attempting to become pregnant
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
Subjects who are vegans or have medical dietary restrictions
Subjects who cannot communicate reliably with the investigator

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Quintiles Drug Research Unit at Guy's Hospital
London, SE1 1YR

Other trials in United Kingdom

About this study

Official title: Comparative Pharmacokinetics of AFOLIA and US Gonal-f® RFF Redi-ject After Single Subcutaneous Application. A Randomised, Open Label, 2-way Cross-over Study

Read the 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
Being tested: Afolia, US Gonal-f®
Keywords: Afolia, Follitropin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AfoliaDrug
Also called Follitropin Alfa
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®Drug
Also called Follitropin Alfa
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

Study groups in NCT02459418
Study group	Role	What they receive
Afolia - US Gonal-f® (Sequence A) Arm	Experimental	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. Receives: Drug: Afolia; Drug: US Gonal-f®
US Gonal-f® - Afolia (Sequence B) Arm:	Active comparator	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 Receives: Drug: Afolia; Drug: US Gonal-f®

What is being measured

The primary outcome is the main question the study is designed to answer.

Baseline Corrected FSH Area Under the Serum Concentration-time Curve From Zero to the Last Quantifiable Measurement [AUC(0-last)]
AUC(0-last) was estimated for baseline corrected FSH in serum by noncompartmental methods using actual elapsed time from dosing. Baseline corrected concentrations were determined by subtracting the baseline concentration (collected immediately prior to dosing in that period) from the postdose concentration.
Geometric mean baseline corrected FSH exposure results are presented for all subjects who received active study drug and had at least 1 measured and valid concentration at a scheduled PK time point after administration of AFOLIA or Gonal-f® RFF.
Measured: From 0 (predose),0.5, 1, 3, 6, 9, 12, 16, 20, 21, 22, 23, 24, 25, 26, 27, 28, 48, 72, 96, 120, 144, 168 and 192 hours postdose.
Baseline Corrected FSH Maximum Serum Concentration (Cmax)
Cmax was estimated for baseline corrected FSH in serum by noncompartmental methods using actual elapsed time from dosing. Baseline corrected concentrations were determined by subtracting the baseline concentration (collected immediately prior to dosing in that period) from the postdose concentration.
Geometric mean baseline corrected FSH exposure results are presented for all subjects who received active study drug and had at least 1 measured and valid concentration at a scheduled PK time point after administration of AFOLIA or Gonal-f® RFF.
Measured: From 0 hours (predose) to 192 hours postdose.

Secondary outcomes (6)

Baseline Corrected FSH Area Under the Serum Concentration-time Curve Extrapolated to Infinity [AUC(0-∞)]
AUC(0-∞) was estimated for baseline corrected FSH in serum by noncompartmental methods using actual elapsed time from dosing. Baseline corrected concentrations were determined by subtracting the baseline concentration (collected immediately prior to dosing in that period) from the postdose concentration.
Geometric mean baseline corrected FSH exposure results are presented for all subjects who received active study drug and had at least 1 measured and valid concentration at a scheduled PK time point after administration of AFOLIA or Gonal-f® RFF.
Measured: From 0 hours (predose) to 192 hours postdose.
Baseline Corrected Time to Reach Maximum FSH Serum Concentration (Tmax)
Tmax was estimated for baseline corrected FSH in serum by noncompartmental methods using actual elapsed time from dosing. Baseline corrected concentrations were determined by subtracting the baseline concentration (collected immediately prior to dosing in that period) from the postdose concentration.
Geometric mean was not calculated for Tmax and the non-transformed results are presented are for all subjects who received active study drug and had Tmax estimated in both periods.
Measured: From 0 hours (predose) to 192 hours postdose.
Baseline Corrected FSH Apparent Terminal Half-life
Apparent terminal half-life was defined as ln2/apparent terminal rate constant (λz). λz is determined by linear regression of the terminal points of the log-linear concentration-time curve. Visual assessment was used to identify the terminal linear phase of the baseline corrected concentration-time profile. A minimum of 3 data points was used for determination.
Terminal half-life was estimated for baseline corrected FSH in serum by noncompartmental methods using actual elapsed time from dosing. Baseline corrected concentrations were determined by subtracting the baseline concentration (collected immediately prior to dosing in that period) from the postdose concentration.
Geometric mean baseline corrected FSH exposure results are presented for all subjects who received active study drug and had at least 1 measured and valid concentration at a scheduled PK time point after administration of AFOLIA or Gonal-f® RFF.
Measured: From 0 hours (predose) to 192 hours postdose.
Baseline Corrected 17ß-Estrodiol (E2) Serum Exposure AUC(0-last)
AUC(0-last) was estimated for baseline corrected E2 in serum by noncompartmental methods using actual elapsed time from dosing. Baseline corrected concentrations were determined by subtracting the baseline concentration (collected immediately prior to dosing in that period) from the postdose concentration.
Geometric mean baseline corrected E2 exposure results are presented for all subjects who received active study drug and had at least 1 measured and valid concentration at a scheduled PD time point after administration of AFOLIA or Gonal-f® RFF.
Measured: From 0 hours (predose) to 192 hours postdose.
Baseline Corrected E2 Cmax
Cmax was estimated for baseline corrected E2 in serum by noncompartmental methods using actual elapsed time from dosing. Baseline corrected concentrations were determined by subtracting the baseline concentration (collected immediately prior to dosing in that period) from the postdose concentration.
Geometric mean baseline corrected E2 exposure results are presented for all subjects who received active study drug and had at least 1 measured and valid concentration at a scheduled PD time point after administration of AFOLIA or Gonal-f® RFF.
Measured: From 0 hours (predose) to 192 hours postdose.
Baseline Corrected E2 Tmax
Tmax was estimated for baseline corrected E2 in serum by noncompartmental methods using actual elapsed time from dosing. Baseline corrected concentrations were determined by subtracting the baseline concentration (collected immediately prior to dosing in that period) from the postdose concentration.
Geometric mean was not calculated for Tmax and the non-transformed results are presented are for all subjects who received active study drug and had Tmax estimated in both periods.
Measured: From 0 hours (predose) to 192 hours postdose.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 May 201519 May 2016

First posted2 Jun 2015 (estimated)
Study start7 May 2015
Primary completion19 May 2016
Study completion19 May 2016

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.
Other trials for Healthy VolunteersStudies 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: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02459418
Sponsor's protocol ID: FIN1002
Status last verified: May 2018
First submitted: 19 May 2015
Last updated: 29 Jun 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparative Pharmacokinetics of AFOLIA and US Gonal-f® RFF Redi-ject After Single Subcutaneous Application. A Randomised, Open Label, 2-way Cross-over Study
ClinicalTrials.gov ID: NCT02459418
Acronym / sponsor ID: FIN1002
Conditions: Healthy Volunteers
Keywords: Afolia, Follitropin
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Fertility Biotech AGIndustry (pharma, biotech, devices)
Study start: 7 May 2015 (actual)
Primary completion: 19 May 2016 (actual)
Study completion: 19 May 2016 (actual)
First posted: 2 Jun 2015 (estimated)
Results: Posted 29 May 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Afolia - US Gonal-f® (Sequence A) Arm	Experimental	Drug: Afolia, Drug: US Gonal-f®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.
US Gonal-f® - Afolia (Sequence B) Arm:	Active comparator	Drug: Afolia, Drug: US Gonal-f®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

Who may qualify

Ages: 18 to 42 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Healthy female volunteers aged 18 to 42 years (inclusive) with a Body mass index of 18.0 to 32.0 kg/m2 (inclusive)
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
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
Subjects with a regular menstruation cycle (25 to 34 days) before initiation of oral contraception
Subjects with both ovaries

Key exclusion criteria (18 listed)

Subjects who do not conform to the above inclusion criteria
Subjects with polycystic ovary syndrome
Subjects with developing follicles or solid ovarian cysts >2 cm or complex cysts regardless of size
Subjects with a history of hypersensitivity to FSH (Ovary Hyperstimulation Syndrome)
Subjects with impaired thyroid function (treated or untreated)

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
AfoliaAlso: Follitropin AlfaDuring 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	Drug	Afolia - US Gonal-f® (Sequence A) Arm, US Gonal-f® - Afolia (Sequence B) Arm:
US Gonal-f®Also: Follitropin AlfaDuring 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	Drug	Afolia - US Gonal-f® (Sequence A) Arm, US Gonal-f® - Afolia (Sequence B) Arm:

Primary outcome

Baseline Corrected FSH Area Under the Serum Concentration-time Curve From Zero to the Last Quantifiable Measurement [AUC(0-last)]
Time frame: From 0 (predose),0.5, 1, 3, 6, 9, 12, 16, 20, 21, 22, 23, 24, 25, 26, 27, 28, 48, 72, 96, 120, 144, 168 and 192 hours postdose.
AUC(0-last) was estimated for baseline corrected FSH in serum by noncompartmental methods using actual elapsed time from dosing. Baseline corrected concentrations were determined by subtracting the baseline concentration (collected immediately prior to dosing in that period) from the postdose concentration. Geometric mean baseline corrected FSH exposure results are presented for all subjects who received active study drug and had at least 1 measured and valid concentration at a scheduled PK time point after administration of AFOLIA or Gonal-f® RFF.
Baseline Corrected FSH Maximum Serum Concentration (Cmax)
Time frame: From 0 hours (predose) to 192 hours postdose.
Cmax was estimated for baseline corrected FSH in serum by noncompartmental methods using actual elapsed time from dosing. Baseline corrected concentrations were determined by subtracting the baseline concentration (collected immediately prior to dosing in that period) from the postdose concentration. Geometric mean baseline corrected FSH exposure results are presented for all subjects who received active study drug and had at least 1 measured and valid concentration at a scheduled PK time point after administration of AFOLIA or Gonal-f® RFF.

6 secondary outcomes

Baseline Corrected FSH Area Under the Serum Concentration-time Curve Extrapolated to Infinity [AUC(0-∞)]
Time frame: From 0 hours (predose) to 192 hours postdose.
Baseline Corrected Time to Reach Maximum FSH Serum Concentration (Tmax)
Time frame: From 0 hours (predose) to 192 hours postdose.
Baseline Corrected FSH Apparent Terminal Half-life
Time frame: From 0 hours (predose) to 192 hours postdose.
Baseline Corrected 17ß-Estrodiol (E2) Serum Exposure AUC(0-last)
Time frame: From 0 hours (predose) to 192 hours postdose.
Baseline Corrected E2 Cmax
Time frame: From 0 hours (predose) to 192 hours postdose.
Baseline Corrected E2 Tmax
Time frame: From 0 hours (predose) to 192 hours postdose.

Results and safety

Results posted to the registry on 29 May 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AFOLIA Then Gonal-f® RFF	21	13
Gonal-f® RFF Then AFOLIA	21	15

Primary outcome: Baseline Corrected FSH Area Under the Serum Concentration-time Curve From Zero to the Last Quantifiable Measurement [AUC(0-last)]

Time frame: From 0 (predose),0.5, 1, 3, 6, 9, 12, 16, 20, 21, 22, 23, 24, 25, 26, 27, 28, 48, 72, 96, 120, 144, 168 and 192 hours postdose.. Geometric mean (Full Range). Unit: nanograms*hours/mL (ng*h/mL)

Measure	AFOLIA n = 36	Gonal-f® RFF n = 33
Value	18.96 (2.2 to 73.2)	10.47 (0.288 to 42.8)

AFOLIA vs Gonal-f® RFF: Geometric LS Mean Ratio: 164.96 (90% CI 137.82 to 197.45)

Population analysed: Analysis was performed on the Pharmacokinetic Analysis Set (PKAS) which includes all subjects who received active study drug and had at least 1 measured and valid concentration at a scheduled PK time point after administration of AFOLIA or Gonal-f® RFF. Only subjects with concentration data for determination of AUC(0-last) are included.

Primary outcome: Baseline Corrected FSH Maximum Serum Concentration (Cmax)

Time frame: From 0 hours (predose) to 192 hours postdose.. Geometric mean (Full Range). Unit: ng/mL

Measure	AFOLIA n = 36	Gonal-f® RFF n = 34
Value	0.4795 (0.21 to 1.13)	0.3692 (0.048 to 1.17)

AFOLIA vs Gonal-f® RFF: Geometric LS Mean Ratio: 123.15 (90% CI 108.12 to 140.28)

Population analysed: This analysis was performed on the PKAS which includes all subjects who received active study drug and had at least 1 measured and valid concentration at a scheduled PK time point after administration of AFOLIA or Gonal-f® RFF. Only subjects with concentration data for determination of Cmax are included.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-emergent adverse event (TEAEs) were reported from study day 1 to study day 35.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AFOLIA	0 of 36 (0%)	21 of 36 (58.3%)	0 of 36
Gonal-f® RFF	0 of 34 (0%)	22 of 34 (64.7%)	0 of 34

Limitations and caveats (from the sponsor): None reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Julian Jenkins, DM FRCOG study director

Fertility Biotech AG

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 Afolia and US Gonal-f® in people with Healthy Volunteers, run by Fertility Biotech AG at 1 site in United Kingdom.

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 9 inclusion and 18 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 29 Jun 2018. 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 United Kingdom. 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 29 May 2018). 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?

Baseline Corrected FSH Area Under the Serum Concentration-time Curve From Zero to the Last Quantifiable Measurement [AUC(0-last)] (time frame: From 0 (predose),0.5, 1, 3, 6, 9, 12, 16, 20, 21, 22, 23, 24, 25, 26, 27, 28, 48, 72, 96, 120, 144, 168 and 192 hours postdose.). 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 NCT02459418.

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 29 Jun 2018.