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.
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.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Recruitment status
completed
Actual enrollment (reported)
97 participants
Study completion date
October 18, 2021
Actual (reported)
Listed locations
1 countries · 1 sites
Trial Relationships
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
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
OTHER
Participants 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.
Drug: Combined oral contraceptives (COC)
Period 2: Second administration of Combined Oral Contraceptive
OTHER
Participants 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.
A commercially available COC consisting of 0.1mg levonorgestrel and 0.02 mg ethinylestradiol will be used and administered open-label.
Also known as: Levonorgestrel/Ethinylestradiol
Period 1: First administration of combined oral contraceptivesPeriod 2: Cenerimod 0.5 mgPeriod 2: Cenerimod 4 mgPeriod 2: Second administration of Combined Oral Contraceptive
Drug CombinationsPharmaceutical PreparationsContraceptives, OralContraceptive Agents, FemaleContraceptive AgentsReproductive Control AgentsPhysiological Effects of DrugsPharmacologic Actions
Study Officials
Clinical Trials
Viatris Innovation GmbH
STUDY DIRECTOR
Enrollment
97 participants (actual enrollment reported by the registry).
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
Model Details: Period 1: Pharmacokinetic study, Period 2: Thorough-QT and Drug-drug-interaction study. Period 3: Accelerated elimination study.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR
Study Record Dates
First Submitted
January 29, 2020
First Posted
February 5, 2020
NCT02917200
Safety and Efficacy Study of Different DAV132 Dose Regimens in Healthy Volunteers
Participants randomized to cenerimod 0.5 mg will receive a single oral dose in the morning from Day 7 to Day 56.
Drug: Combined oral contraceptives (COC)
Period 2: Cenerimod 4 mg
EXPERIMENTAL
Participants randomized to cenerimod 4 mg will receive a single oral dose in the morning from Day 7 to Day 56.
Drug: Combined oral contraceptives (COC)
Period 2: Moxifloxacin
OTHER
Participants randomized to moxifloxacin will receive a single oral 400 mg dose in the morning of Day 42.
Drug: Moxifloxacin 400mg
Period 2: Placebo
PLACEBO COMPARATOR
Participants randomized to placebo will receive a single oral dose of placebo in the morning from Day 7 to Day 56.
Drug: Matching Placebo
Period 3: Cenerimod 0.5 mg and charcoal
EXPERIMENTAL
Participants 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.
Drug: Cenerimod 0.5 mgOther: Charcoal, activated
Period 3: Cenerimod 4 mg and charcoal
EXPERIMENTAL
Participants randomized to cenerimod 4 mg in Period 2 will receive 50 g of activated charcoal every 12 hours from Day 57 to Day 67.
Drug: Cenerimod 4 mgOther: Charcoal, activated
Period 3: Cenerimod elimination period
NO INTERVENTION
Participants 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.
A commercially available formulation of moxifloxacin 400 mg will be used and administered open-label. All tablets will be from the same batch.
Cenerimod matching placebo tablets will be administered once daily orally in the morning.
Period 2: Placebo
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.
Chemical Actions and Uses
Therapeutic Uses
Norgestrel
Norpregnenes
Norpregnanes
Norsteroids
Steroids
Fused-Ring Compounds
Polycyclic Compounds
Norpregnatrienes
Estrogenic Steroids, Alkylated
Estradiol Congeners
Gonadal Steroid Hormones
Gonadal Hormones
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Fluoroquinolones
4-Quinolones
Quinolones
Quinolines
Heterocyclic Compounds, 2-Ring
Heterocyclic Compounds, Fused-Ring
Heterocyclic Compounds
Carbon
Elements
Inorganic Chemicals
Study Start
January 31, 2020
Actual (reported)
Primary Completion
September 14, 2021
Actual (reported)
Study Completion
October 18, 2021
Actual (reported)
Last Updated
September 22, 2025
Record last verified: 2022-11
Data Sharing
IPD Sharing
Will not share
Source record
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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