To Study the Effect of Cenerimod on the Electrical Activity of the Heart, in Men and Women. To Study the Effect of Cenerimod on the Use of Oral Contraceptives in Women. To Study the Effect That Charcoal Has on the Elimination of Cenerimod From the Body, in Women and Men.
A Single-center, Double-blind for Cenerimod, Open-label for Moxifloxacin, Placebo-controlled, Parallel-group, Randomized Study in Healthy Male and Female Subjects to Investigate I: the Effect of Cenerimod on the QTc Interval II: the Effect of Cenerimod on the Pharmacokinetics of Combined Oral Contraceptives III: the Effect of Charcoal on the Pharmacokinetics of Cenerimod.
2 other identifiers
interventional
97
1 country
1
Brief Summary
This is a single-center, randomized, double-blind for cenerimod, open-label for moxifloxacin, placebo- and moxifloxacin-controlled, parallel-group study to investigate the effect of cenerimod on the duration of the QT interval in healthy male and female participants. Participants will be randomly assigned to one of the 4 treatments: placebo, cenerimod 0.5 mg, cenerimod 4 mg or moxifloxacin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2020
CompletedStudy Start
First participant enrolled
January 31, 2020
CompletedFirst Posted
Study publicly available on registry
February 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 14, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 18, 2021
CompletedSeptember 22, 2025
November 1, 2022
1.6 years
January 29, 2020
September 16, 2025
Conditions
Outcome Measures
Primary Outcomes (13)
Placebo-corrected, change-from-baseline QTcF (ΔΔQTcF)
ECG variables will be assessed from ECGs extracted in replicates at predefined time points from continuous 24 hour Holter ECG recordings.
Day 6, 7, 14, 21, 35, and 56.
Maximum plasma concentration (Cmax): levonorgestrel
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Day 1 to Day 3; Day 42 to Day 44
Maximum plasma concentration (Cmax): ethinylestradiol
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Day 1 to Day 3; Day 42 to Day 44
Time to reach Cmax (tmax): levonorgestrel
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Day 1 to Day 3; Day 42 to Day 44
Time to reach Cmax (tmax): ethinylestradiol
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Day 1 to Day 3; Day 42 to Day 44
The area under the plasma concentration-time curve (AUC) from zero to infinity (AUC0-inf): levonorgestrel
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Day 1 to Day 3; Day 42 to Day 44
The area under the plasma concentration-time curve (AUC) from zero to t (AUC0-t): levonorgestrel
Blood samples for determination of PK parameters will be collected at predefined
Day 1 to Day 3; Day 42 to Day 44
The area under the plasma concentration-time curve (AUC) from zero to infinity (AUC0-inf): ethinylestradiol
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Day 1 to Day 3; Day 42 to Day 44
The area under the plasma concentration-time curve (AUC) from zero to t (AUC0-t): ethinylestradiol
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Day 1 to Day 3; Day 42 to Day 44
Terminal elimination half-life (t1/2): levonorgestrel
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Day 56 to Day 68
Terminal elimination half-life (t1/2): ethinylestradiol
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Day 56 to Day 68
Terminal elimination half-life (t1/2): cenerimod
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Day 56 to Day 68
Area under the plasma concentration-time curve (AUC) from Day 56 to infinity (AUC56-inf) for cenerimod
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Day 56 to Day 68
Secondary Outcomes (3)
Change from baseline in total lymphocyte count to each time point
Day 5, Day 7, Day 14, Day 21, Day 35, Day 56, Day 57, Day 58, Day 1, Day 64, and Day 67
Maximum plasma concentration (Cmax): cenerimod
Day 7, Day 14, Day 21, Day 35, and Day 56
Time to reach Cmax (tmax): cenerimod
Day 7, Day 14, Day 21, Day 35, and Day 56
Study Arms (9)
Period 1: First administration of combined oral contraceptives
OTHERParticipants randomized to placebo or cenerimod will receive a single oral dose of levonorgestrel (100 μg) and ethinylestradiol (20 μg) in the morning on Day 1.
Period 2: Second administration of Combined Oral Contraceptive
OTHERParticipants randomized to placebo or cenerimod will receive a single oral dose of levonorgestrel (100 μg) and ethinylestradiol (20 μg) in the morning on Day 42.
Period 2: Cenerimod 0.5 mg
EXPERIMENTALParticipants randomized to cenerimod 0.5 mg will receive a single oral dose in the morning from Day 7 to Day 56.
Period 2: Cenerimod 4 mg
EXPERIMENTALParticipants randomized to cenerimod 4 mg will receive a single oral dose in the morning from Day 7 to Day 56.
Period 2: Moxifloxacin
OTHERParticipants randomized to moxifloxacin will receive a single oral 400 mg dose in the morning of Day 42.
Period 2: Placebo
PLACEBO COMPARATORParticipants randomized to placebo will receive a single oral dose of placebo in the morning from Day 7 to Day 56.
Period 3: Cenerimod 0.5 mg and charcoal
EXPERIMENTALParticipants randomized to cenerimod 0.5 mg in Period 2 will receive 50 g of activated charcoal every 12 hours from Day 57 to Day 67.
Period 3: Cenerimod 4 mg and charcoal
EXPERIMENTALParticipants randomized to cenerimod 4 mg in Period 2 will receive 50 g of activated charcoal every 12 hours from Day 57 to Day 67.
Period 3: Cenerimod elimination period
NO INTERVENTIONParticipants randomized to cenerimod 0.5 mg or 4 mg in Period 2 will receive no treatment (i.e., activated charcoal from Day 57 to Day 67) but will have blood samples taken.
Interventions
A commercially available COC consisting of 0.1mg levonorgestrel and 0.02 mg ethinylestradiol will be used and administered open-label.
A commercially available formulation of moxifloxacin 400 mg will be used and administered open-label. All tablets will be from the same batch.
This will be administered orally as a film-coated tablet in the morning.
This will be administered orally as a film-coated tablet in the morning.
Granules for oral suspension will be used and administered open-label.
Cenerimod matching placebo tablets will be administered once daily orally in the morning.
Eligibility Criteria
You may qualify if:
- Signed informed consent in a language understandable to the participant prior to any study-mandated procedure.
- Body mass index of 18.0 to 29.9 kg/m\^2 (inclusive) at the screening.
- No clinically relevant findings on the physical examination at screening.
- Systolic blood pressure 90 to 145 mmHg, diastolic blood pressure 45 to 90 mmHg, and pulse rate 50 to 100 bpm (inclusive), measured on the same arm, after 5 min in the supine position at screening and on Day -1.
- lead ECG without clinically relevant abnormalities, measured after 5 min in the supine position at screening and on admission.
- No clinically relevant findings in clinical laboratory tests (hematology, clinical chemistry, and urinalysis) at screening and on admission.
- Negative results from urine drug screen and breath alcohol tests at screening and on admission.
- Women of non-childbearing potential (i.e., postmenopausal \[defined as 12 consecutive months with no menses without an alternative medical cause, confirmed by a follicle-stimulating hormone test\], with previous bilateral salpingectomy, bilateral salpingo-oophorectomy or hysterectomy, or with premature ovarian failure \[confirmed by a specialist\]).
- Women of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1. They must consistently and correctly use (from screening, during the entire study, and up to end-of-study) a highly effective method of contraception with a failure rate of less than 1% per year (i.e., intrauterine device, bilateral tubal occlusion) or be sexually inactive, or have a vasectomized partner. Hormonal contraceptive must not be used within 3 months prior to screening until end of study visit.
You may not qualify if:
- Previous exposure to cenerimod.
- Previous exposure to combined oral contraceptive(s), moxifloxacin, or charcoal within 3 months prior to screening.
- Known hypersensitivity to treatments of the same class as cenerimod, or any of the excipients.
- Known hypersensitivity to combined oral contraceptive(s), moxifloxacin, or charcoal or treatments of the same class, or any of their excipients.
- Any contraindication to combined oral contraceptive(s) or moxifloxacin treatment.
- Known hypersensitivity or allergy to natural rubber latex.
- Lymphopenia (\< 1000 cells/μL) at Screening and on Day -1.
- Familial history of sick-sinus syndrome.
- Any cardiac condition or illness (including ECG abnormalities) with a potential to increase the cardiac risk of the subject based on the standard 12-lead ECG at screening.
- History of major medical or surgical disorders which, in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatment (appendectomy and herniotomy allowed, cholecystectomy not allowed).
- Acute, ongoing, recurrent, or chronic systemic disease able to interfere with the evaluation.
- Clinically relevant history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions.
- Any immunosuppressive treatment within 6 weeks or 5 terminal half-lives (t½), whichever is longer, before first study drug administration.
- History or clinical evidence of alcoholism or drug abuse.
- Excessive caffeine consumption, defined as 800 mg or more per day at screening.
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Site 1
Rennes, 35042, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Viatris Innovation GmbH
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The Thorough QT/QTc prolongation (TQT) study is a double-blind parallel study. The accelerated elimination and the combined oral contraceptive pharmacokinetic drug-drug-interaction are open-label.
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2020
First Posted
February 5, 2020
Study Start
January 31, 2020
Primary Completion
September 14, 2021
Study Completion
October 18, 2021
Last Updated
September 22, 2025
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share