Healthy Female ParticipantsPhase 1NCT04131517

A Study to Test the Interaction of Padsevonil With Oral Contraceptives in Healthy Female Participants

A Phase 1 study testing Padsevonil and Microgynon 30® in people with Healthy Female Participants, run by UCB Biopharma SRL at 1 site in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of the study is to investigate the effect of steady-state padsevonil on the pharmacokinetic of a single dose oral contraceptive. Read more about this study

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Healthy Female Participants
What is being tested?: Padsevonil and Microgynon 30®
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteUnited Kingdom
Study dates: 23 Oct 2019to 22 May 2020
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 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Participant must be aged 18 years of age or greater, at the time of signing the informed consent
Participant must be a premenopausal female with no indication of abnormal or gestational/lactational hypothalamic-pituitary-ovarian function. Menopause will be defined for the purpose of this study as amenorrhea of ≥12 months for which no other reason has been identified
Participant must not be pregnant or breastfeeding. Participant must agree to use an effective form of contraception (other than hormonal methods) for the duration of the Treatment Period and for at least 90 days (or 5 terminal half-lives) after the last dose of study medication
Participant must be in good physical and mental health as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
Participant must have body weight of at least 45 kg and body mass index within the range 18 to 30 kg/m^2 (inclusive)

Who cannot join

Participant has a history of discontinued use of oral contraceptives (OC) for medical reasons
Participant has any medical reason that would contraindicate the administration of OC (per label)
Participant has used any of the following within the specified time period prior to first dose of study medication:
Oral contraceptive or oral hormone replacement therapy within prior 30 days
Implanted hormonal contraceptives within prior 6 months
Injectable contraceptives within prior 12 months

Show all 13Show fewer

Topical controlled-delivery contraceptives within prior 3 months
Hormone-releasing intrauterine devices ('coils') within prior 3 months
Participant has other relevant gynecological disorders (such as premature ovarian failure or endometriosis)
Participant has any clinically relevant electrocardiogram (ECG) finding at the Screening Visit or at Baseline (Day -1) that, in the opinion of the Investigator, increases the risks associated with participating in the study. In addition, any study participant with any of the following findings will be excluded:
QT interval corrected for heart rate using Bazett's formula (QTcB) or Fridericia's formula (QTcF) >450 ms in 2 of 3 ECG recordings;
other conduction abnormalities (defined as PR interval ≥220 ms);
irregular rhythms other than sinus arrhythmia or occasional, rare supraventricular or rare ventricular ectopic beats. In case of an out-of-range result, 1 repeat will be allowed. If the result is out-of-range again, the study participant cannot be included

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Up0035 001
London

Other trials in United Kingdom

About this study

Official title: An Open-Label, Randomized, Two-Way Crossover Study to Investigate the Potential Pharmacokinetic Interaction of Padsevonil With Oral Contraceptives in Healthy Female Participants

The purpose of the study is to investigate the effect of steady-state padsevonil on the pharmacokinetic of a single dose oral contraceptive.

Conditions: Healthy Female Participants
Being tested: Padsevonil, Microgynon 30®
Keywords: Padsevonil, Contraceptives, Healthy female participants

What participants receive

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

PadsevonilDrug
Study Medication: Padsevonil Dosage formulation: Oral tablets; 400 mg BID (Part 1) and 200 mg BID (Part 2)
Microgynon 30®Drug
Study Medication: Microgynon 30® Dosage formulation: Oral tablets Dose: Ethinyl estradiol 30 µg + levonorgestrel 150 µg

Study groups in NCT04131517
Study group	Role	What they receive
Oral contraceptive	Experimental	Participants will receive oral contraceptive in Period 2 of Sequence A and Period 1 of Sequence B of Part 1 and Part 2. Receives: Drug: Microgynon 30®
Oral contraceptive + padsevonil	Experimental	Participants will receive padsevonil + oral contraceptive in Period 1 of Sequence A and Period 2 of Sequence B of Part 1 and Part 2. Receives: Drug: Padsevonil; Drug: Microgynon 30®

What is being measured

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

Maximum Observed Plasma Concentration (Cmax) of Ethinylestradiol in Part 1
Cmax is maximum observed plasma concentration of ethinylestradiol (EE). Values were determined from the observed concentration and time data. This outcome measure was planned to be analyzed for 'Oral Contraceptive Alone' and 'PSL + Oral Contraceptive' arms.
Measured: Day 13, 14, 15, 34, 35, 36 during Treatment Sequence A and on Day 1, 2, 3, 30, 31 and 32 during Treatment Sequence B
Maximum Observed Plasma Concentration (Cmax) of Levonorgestrel in Part 1
Cmax is maximum observed plasma concentration of levonorgestrel. Values were determined from the observed concentration and time data. This outcome measure was planned to be analyzed for 'Oral Contraceptive Alone' and 'PSL + Oral Contraceptive' arms.
Measured: Day 13, 14, 15, 34, 35, 36 during Treatment Sequence A and on Day 1, 2, 3, 30, 31 and 32 during Treatment Sequence B
Maximum Observed Plasma Concentration (Cmax) of Ethinylestradiol in Part 2
Cmax is maximum observed plasma concentration of ethinylestradiol.
Measured: Day 9, 10, 11, 26, 27 and 28 during Treatment Sequence A and on Day 1, 2, 3, 26, 27 and 28 during Treatment Sequence B
Maximum Observed Plasma Concentration (Cmax) of Levonorgestrel in Part 2
Cmax is maximum observed plasma concentration of levonorgestrel.
Measured: Day 9, 10, 11, 26, 27 and 28 during Treatment Sequence A and on Day 1, 2, 3, 26, 27 and 28 during Treatment Sequence B
Area Under the Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) of Ethinylestradiol in Part 1
Area under the concentration time curve from time 0 extrapolated to infinity for ethinylestradiol was reported. This outcome measure was planned to be analyzed for 'Oral Contraceptive Alone' and 'PSL + Oral Contraceptive' arms.
Measured: Day 13, 14, 15, 34, 35, 36 during Treatment Sequence A and on Day 1, 2, 3, 30, 31 and 32 during Treatment Sequence B
Area Under the Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) of Levonorgestrel in Part 1
AUC0-inf is the area under the concentration time curve from time 0 extrapolated to infinity for levonorgestrel was reported. This outcome measure was planned to be analyzed for 'Oral Contraceptive Alone' and 'PSL + Oral Contraceptive' arms.
Measured: Day 13, 14, 15, 34, 35, 36 during Treatment Sequence A and on Day 1, 2, 3, 30, 31 and 32 during Treatment Sequence B
Area Under the Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) of Ethinylestradiol in Part 2
AUC0-inf is the area under the concentration time curve from time 0 extrapolated to infinity of ethinylestradiol.
Measured: Day 9, 10, 11, 26, 27 and 28 during Treatment Sequence A and on Day 1, 2, 3, 26, 27 and 28 during Treatment Sequence B
Area Under the Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) of Levonorgestrel in Part 2
AUC0-inf is the area under the concentration time curve from time 0 extrapolated to infinity of levonorgestrel.
Measured: Day 9, 10, 11, 26, 27 and 28 during Treatment Sequence A and on Day 1, 2, 3, 26, 27 and 28 during Treatment Sequence B

Secondary outcomes (8)

Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) in Part 1
An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs were defined as AEs with a start date/time on or after the first dose of study medication (OC or PSL) or any unresolved event already present before administration of study medication that worsened in intensity following exposure to the treatment.
Measured: From Baseline up to Safety Follow-Up during Treatment Sequences A and B (up to Day 46)
Percentage of Participants With Serious TEAEs in Part 1
Serious AEs were defined as any untoward medical occurrence that resulted in death, is life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability, is a congenital anomaly, or is an important medical event which based on medical or scientific judgement may jeopardize the participants, or may require medical or surgical intervention to prevent any of the above.
Measured: From Baseline up to Safety Follow-Up during Treatment Sequences A and B (up to Day 46)
Percentage of Participants With TEAEs in Part 2
An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs were defined as AEs with a start date/time on or after the first dose of study medication (OC or PSL) or any unresolved event already present before administration of study medication that worsened in intensity following exposure to the treatment.
Measured: From Baseline up to Safety Follow-Up during Treatment Sequences A and B (up to Day 42)
Percentage of Participants With Serious TEAEs in Part 2
Serious AEs were defined as any untoward medical occurrence that resulted in death, is life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability, is a congenital anomaly, or is an important medical event which based on medical or scientific judgement may jeopardize the participants, or may require medical or surgical intervention to prevent any of the above.
Measured: From Baseline up to Safety Follow-Up during Treatment Sequences A and B (up to Day 42)
Steady State Plasma Concentration (Cmax,ss) of Padsevonil in Part 1
Maximum observed plasma concentration of padsevonil at steady-state was reported. This outcome measure was planned to be analyzed for 'PSL + Oral contraceptive' and 'PSL Alone' arms.
Measured: Day 12 and 13 (Sequence A) and Day 29 and 30 (Sequence B)
Steady State Plasma Concentration (Cmax,ss) of Padsevonil in Part 2
Cmax,ss is the steady state plasma concentration of padsevonil.
Measured: Day 8 and 9 (Sequence A) and Day 25 and 26 (Sequence B)
Area Under the Concentration-time Curve From Time 0 to Time Tau (AUC[0-tau]) of Padsevonil in Part 1
Area under the concentration-time curve over a dosing interval from time 0 to tau for padsevonil was reported. This outcome measure was planned to be analyzed for 'PSL + Oral contraceptive' and 'PSL Alone' arms.
Measured: Day 12 and 13 (Sequence A) and Day 29 and 30 (Sequence B)
Area Under the Concentration-time Curve From Time 0 to Time Tau (AUC[0-tau]) of Padsevonil in Part 2
AUC0-tau is area under the concentration-time curve over a dosing interval from time 0 to tau of padsevonil.
Measured: Day 8 and 9 (Sequence A) and Day 25 and 26 (Sequence B)

Timeline

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

23 Oct 201922 May 2020

First posted18 Oct 2019
Study start23 Oct 2019
Primary completion22 May 2020
Study completion22 May 2020

Why it stopped: Based on available data, UCB has decided to stop development of padsevonil as adjunctive treatment of focal-onset seizures

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 Healthy Female ParticipantsStudies of the same condition, open and under way.
More trials run by UCB Biopharma SRLThe sponsor's other registered studies.
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: Crossover
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04131517
Sponsor's protocol ID: UP0035
Other IDs: 2019-002194-54, 2019
Status last verified: Jun 2021
First submitted: 16 Oct 2019
Last updated: 24 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Due to the small sample size in this trial, Individual Patient Data cannot be adequately anonymized and there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.

Publications

Chanteux H, MacPherson M, Kramer H, Otoul C, Okagaki T, Rospo C, De Bruyn S, Watling M, Bani M, Sciberras D. Overview of preclinical and clinical studies investigating pharmacokinetics and drug-drug interactions of padsevonil. Expert Opin Drug Metab Toxicol. 2024 Aug;20(8):841-855. doi: 10.1080/17425255.2024.2373108. Epub 2024 Jul 9.
PubMed 38932723

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Randomized, Two-Way Crossover Study to Investigate the Potential Pharmacokinetic Interaction of Padsevonil With Oral Contraceptives in Healthy Female Participants
ClinicalTrials.gov ID: NCT04131517
Acronym / sponsor ID: UP0035
Conditions: Healthy Female Participants
Keywords: Padsevonil, Contraceptives, Healthy female participants
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Based on available data, UCB has decided to stop development of padsevonil as adjunctive treatment of focal-onset seizures
Enrolment: 14 participants (actual)
Lead sponsor: UCB Biopharma SRLIndustry (pharma, biotech, devices)
Study start: 23 Oct 2019 (actual)
Primary completion: 22 May 2020 (actual)
Study completion: 22 May 2020 (actual)
First posted: 18 Oct 2019 (actual)
Results: Posted 24 Jun 2021

Clinical summary

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

The purpose of the study is to investigate the effect of steady-state padsevonil on the pharmacokinetic of a single dose oral contraceptive.

Study design

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

Arm	Type	Receives
Oral contraceptive	Experimental	Drug: Microgynon 30®Participants will receive oral contraceptive in Period 2 of Sequence A and Period 1 of Sequence B of Part 1 and Part 2.
Oral contraceptive + padsevonil	Experimental	Drug: Padsevonil, Drug: Microgynon 30®Participants will receive padsevonil + oral contraceptive in Period 1 of Sequence A and Period 2 of Sequence B of Part 1 and Part 2.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Participant must be aged 18 years of age or greater, at the time of signing the informed consent
Participant must be a premenopausal female with no indication of abnormal or gestational/lactational hypothalamic-pituitary-ovarian function. Menopause will be defined for the purpose of this study as amenorrhea of ≥12 months for which no other reason has been identified
Participant must not be pregnant or breastfeeding. Participant must agree to use an effective form of contraception (other than hormonal methods) for the duration of the Treatment Period and for at least 90 days (or 5 terminal half-lives) after the last dose of study medication
Participant must be in good physical and mental health as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
Participant must have body weight of at least 45 kg and body mass index within the range 18 to 30 kg/m^2 (inclusive)

Key exclusion criteria (13 listed)

Participant has a history of discontinued use of oral contraceptives (OC) for medical reasons
Participant has any medical reason that would contraindicate the administration of OC (per label)
Participant has used any of the following within the specified time period prior to first dose of study medication:
Participant has other relevant gynecological disorders (such as premature ovarian failure or endometriosis)
Participant has any clinically relevant electrocardiogram (ECG) finding at the Screening Visit or at Baseline (Day -1) that, in the opinion of the Investigator, increases the risks associated with participating in the study. In addition, any study participant with any of the following findings will be excluded:

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
PadsevonilStudy Medication: Padsevonil Dosage formulation: Oral tablets; 400 mg BID (Part 1) and 200 mg BID (Part 2)	Drug	Oral contraceptive + padsevonil
Microgynon 30®Study Medication: Microgynon 30® Dosage formulation: Oral tablets Dose: Ethinyl estradiol 30 µg + levonorgestrel 150 µg	Drug	Oral contraceptive, Oral contraceptive + padsevonil

Primary outcome

Maximum Observed Plasma Concentration (Cmax) of Ethinylestradiol in Part 1
Time frame: Day 13, 14, 15, 34, 35, 36 during Treatment Sequence A and on Day 1, 2, 3, 30, 31 and 32 during Treatment Sequence B
Cmax is maximum observed plasma concentration of ethinylestradiol (EE). Values were determined from the observed concentration and time data. This outcome measure was planned to be analyzed for 'Oral Contraceptive Alone' and 'PSL + Oral Contraceptive' arms.
Maximum Observed Plasma Concentration (Cmax) of Levonorgestrel in Part 1
Time frame: Day 13, 14, 15, 34, 35, 36 during Treatment Sequence A and on Day 1, 2, 3, 30, 31 and 32 during Treatment Sequence B
Cmax is maximum observed plasma concentration of levonorgestrel. Values were determined from the observed concentration and time data. This outcome measure was planned to be analyzed for 'Oral Contraceptive Alone' and 'PSL + Oral Contraceptive' arms.
Maximum Observed Plasma Concentration (Cmax) of Ethinylestradiol in Part 2
Time frame: Day 9, 10, 11, 26, 27 and 28 during Treatment Sequence A and on Day 1, 2, 3, 26, 27 and 28 during Treatment Sequence B
Cmax is maximum observed plasma concentration of ethinylestradiol.
Maximum Observed Plasma Concentration (Cmax) of Levonorgestrel in Part 2
Time frame: Day 9, 10, 11, 26, 27 and 28 during Treatment Sequence A and on Day 1, 2, 3, 26, 27 and 28 during Treatment Sequence B
Cmax is maximum observed plasma concentration of levonorgestrel.
Area Under the Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) of Ethinylestradiol in Part 1
Time frame: Day 13, 14, 15, 34, 35, 36 during Treatment Sequence A and on Day 1, 2, 3, 30, 31 and 32 during Treatment Sequence B
Area under the concentration time curve from time 0 extrapolated to infinity for ethinylestradiol was reported. This outcome measure was planned to be analyzed for 'Oral Contraceptive Alone' and 'PSL + Oral Contraceptive' arms.
Area Under the Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) of Levonorgestrel in Part 1
Time frame: Day 13, 14, 15, 34, 35, 36 during Treatment Sequence A and on Day 1, 2, 3, 30, 31 and 32 during Treatment Sequence B
AUC0-inf is the area under the concentration time curve from time 0 extrapolated to infinity for levonorgestrel was reported. This outcome measure was planned to be analyzed for 'Oral Contraceptive Alone' and 'PSL + Oral Contraceptive' arms.
Area Under the Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) of Ethinylestradiol in Part 2
Time frame: Day 9, 10, 11, 26, 27 and 28 during Treatment Sequence A and on Day 1, 2, 3, 26, 27 and 28 during Treatment Sequence B
AUC0-inf is the area under the concentration time curve from time 0 extrapolated to infinity of ethinylestradiol.
Area Under the Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) of Levonorgestrel in Part 2
Time frame: Day 9, 10, 11, 26, 27 and 28 during Treatment Sequence A and on Day 1, 2, 3, 26, 27 and 28 during Treatment Sequence B
AUC0-inf is the area under the concentration time curve from time 0 extrapolated to infinity of levonorgestrel.

8 secondary outcomes

Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) in Part 1
Time frame: From Baseline up to Safety Follow-Up during Treatment Sequences A and B (up to Day 46)
Percentage of Participants With Serious TEAEs in Part 1
Time frame: From Baseline up to Safety Follow-Up during Treatment Sequences A and B (up to Day 46)
Percentage of Participants With TEAEs in Part 2
Time frame: From Baseline up to Safety Follow-Up during Treatment Sequences A and B (up to Day 42)
Percentage of Participants With Serious TEAEs in Part 2
Time frame: From Baseline up to Safety Follow-Up during Treatment Sequences A and B (up to Day 42)
Steady State Plasma Concentration (Cmax,ss) of Padsevonil in Part 1
Time frame: Day 12 and 13 (Sequence A) and Day 29 and 30 (Sequence B)
Steady State Plasma Concentration (Cmax,ss) of Padsevonil in Part 2
Time frame: Day 8 and 9 (Sequence A) and Day 25 and 26 (Sequence B)
Area Under the Concentration-time Curve From Time 0 to Time Tau (AUC[0-tau]) of Padsevonil in Part 1
Time frame: Day 12 and 13 (Sequence A) and Day 29 and 30 (Sequence B)
Area Under the Concentration-time Curve From Time 0 to Time Tau (AUC[0-tau]) of Padsevonil in Part 2
Time frame: Day 8 and 9 (Sequence A) and Day 25 and 26 (Sequence B)

Results and safety

Results posted to the registry on 24 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part 1 Sequence A	7	7
Part 1 Sequence B	7	7

Primary outcome: Maximum Observed Plasma Concentration (Cmax) of Ethinylestradiol in Part 1

Time frame: Day 13, 14, 15, 34, 35, 36 during Treatment Sequence A and on Day 1, 2, 3, 30, 31 and 32 during Treatment Sequence B. Geometric mean (95% Confidence Interval). Unit: picograms per milliliter (pg/mL)

Measure	Part 1 Oral Contraceptive Alone (PKS) n = 14	Part 1 PSL + Oral Contraceptive (PKS) n = 14
Value	41.17 (34.07 to 49.76)	42.83 (36.23 to 50.65)

Part 1 Oral Contraceptive Alone (PKS) vs Part 1 PSL + Oral Contraceptive (PKS): Geometric LS Mean ratio: 1.0404 (90% CI 0.94156 to 1.1497)

Population analysed: Pharmacokinetic Set (PKS) included all study participants who had no important protocol deviations affecting the PK of EE, LN, or PSL and its metabolite and for whom at least 1 measurable concentration existed.

Primary outcome: Maximum Observed Plasma Concentration (Cmax) of Levonorgestrel in Part 1

Time frame: Day 13, 14, 15, 34, 35, 36 during Treatment Sequence A and on Day 1, 2, 3, 30, 31 and 32 during Treatment Sequence B. Geometric mean (95% Confidence Interval). Unit: pg/mL

Measure	Part 1 Oral Contraceptive Alone (PKS) n = 14	Part 1 PSL + Oral Contraceptive (PKS) n = 14
Value	2868 (2204 to 3733)	2560 (2045 to 3206)

Part 1 Oral Contraceptive Alone (PKS) vs Part 1 PSL + Oral Contraceptive (PKS): Geometric LS Mean ratio: 0.89272 (90% CI 0.76892 to 1.0364)

Population analysed: Pharmacokinetic Set included all study participants who had no important protocol deviations affecting the PK of EE, LN, or PSL and its metabolite and for whom at least 1 measurable concentration existed.

Primary outcome: Maximum Observed Plasma Concentration (Cmax) of Ethinylestradiol in Part 2

Time frame: Day 9, 10, 11, 26, 27 and 28 during Treatment Sequence A and on Day 1, 2, 3, 26, 27 and 28 during Treatment Sequence B

Population analysed: Analysis of this outcome measure was not performed because no study participants started Part 2 due to the COVID-19 pandemic. Later, the study was terminated.

Primary outcome: Maximum Observed Plasma Concentration (Cmax) of Levonorgestrel in Part 2

Time frame: Day 9, 10, 11, 26, 27 and 28 during Treatment Sequence A and on Day 1, 2, 3, 26, 27 and 28 during Treatment Sequence B

Population analysed: No study participants started Part 2 due to the COVID-19 pandemic. Later, the program developing PSL in focal-onset seizures was stopped and the study was terminated.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Baseline up to Safety Follow-Up during Treatment Sequences A and B in Part 1 (up to Day 46). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part 1 PSL + Oral Contraceptive (SS)	0 of 14 (0%)	12 of 14 (85.7%)	0 of 14
Part 1 Oral Contraceptive Alone (SS)	0 of 14 (0%)	7 of 14 (50%)	0 of 14
Part 1 PSL Alone (SS)	0 of 14 (0%)	14 of 14 (100%)	0 of 14

Limitations and caveats (from the sponsor): The study was terminated on 22 May 2020 because the program developing padsevonil in focal-onset seizures was stopped.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38932723Chanteux H, MacPherson M, Kramer H, Otoul C, Okagaki T, Rospo C, De Bruyn S, Watling M, Bani M, Sciberras D. Overview of preclinical and clinical studies investigating pharmacokinetics and drug-drug interactions of padsevonil. Expert Opin Drug Metab Toxicol. 2024 Aug;20(8):841-855. doi: 10.1080/17425255.2024.2373108. Epub 2024 Jul 9.
Individual participant dataSharing planned: No. Due to the small sample size in this trial, Individual Patient Data cannot be adequately anonymized and there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.

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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.

UCB Cares study director

001 844 599 2273 (UCB)

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 Padsevonil and Microgynon 30® in people with Healthy Female Participants, run by UCB Biopharma SRL 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 5 inclusion and 13 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: stopped early, as of the sponsor's last update on 24 Jun 2021. 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 24 Jun 2021). 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?

Maximum Observed Plasma Concentration (Cmax) of Ethinylestradiol in Part 1 (time frame: Day 13, 14, 15, 34, 35, 36 during Treatment Sequence A and on Day 1, 2, 3, 30, 31 and 32 during Treatment Sequence B). The study lists 8 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 NCT04131517, 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 24 Jun 2021.