Healthy VolunteersPhase 1TQT2NCT04168723
TQT2 Study to Evaluate the Effect of MD1003 on Cardiac Repolarization in Healthy Adult Subjects
A Phase 1 study testing MD1003 and Moxifloxacin 400mg in people with Healthy Volunteers, run by MedDay Pharmaceuticals SA at 1 site in United Kingdom.
Trial summary
This is a Phase 1, single-center, double-blind, randomized, placebo- and positive controlled, double-dummy, parallel-group, repeated-dose study with a nested cross-over comparison between moxifloxacin and placebo to evaluate the effect of MD1003 on cardiac repolarization in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- MD1003 and Moxifloxacin 400mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Nov 2019to 5 Mar 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent form prior to performing any of the Screening Visit procedures.
- Males and females between 18 to 55 years of age, inclusive, at the Screening Visit.
- Female subjects of childbearing potential must not be planning to become pregnant, must not be breastfeeding, and must have a negative serum pregnancy test at Screening and negative urine pregnancy test on Day-2.
- Sexually active female subjects of childbearing potential (i.e. women who are not post-menopausal [12 months of spontaneous amenorrhea without an alternative medical cause and follicle stimulating hormone (FSH) levels in the post-menopausal range for the laboratory involved] or who have not had a documented hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) and all male subjects (who have not been surgically sterilized by documented vasectomy) must agree to use highly effective methods of contraception during the study and for 8 weeks after the last dose of study drug. Please refer to Section 5.4.4 for acceptable methods of contraception.
- Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to the screening.
- Body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive, at the Screening Visit.
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- Healthy adult subjects with suitable veins for cannulation.
- Healthy, determined by pre-study medical evaluation (medical history, renal function, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations).
- Supine vital signs should be within the normal range at Screening and Day -2:
- oral body temperature between 35.0°C - 37.5°C;
- systolic BP, 90 - 140 mm Hg;
- diastolic BP, 40 - 90 mm Hg;
- pulse rate, 40 - 100 bpm.
- Subjects should have serum potassium, calcium, and magnesium levels within the normal range at Screening and at admission on Day -2 (morning in fasted condition).
- Subjects should fulfil the following ECG parameters criteria at Screening and Day -2:
- Normal sinus rhythm (HR between 40 beats per minute [bpm] and 100 bpm, inclusive);
- Fridericia QTc interval corrected (QTcF)≤ 450 msec;
- QRS interval ≤110 msec; and confirmed by manual over-read if > 110 msec;
- PR interval ≤220 msec.
Who cannot join
- Subject has clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological or psychiatric disorder(s) as determined by the Principal Investigator or designee.
- Subject has any disorder that would interfere with the absorption, distribution, metabolism or excretion of drugs.
- Subject has any concurrent disease or condition that, in the opinion of the Principal Investigator, would make the subject unsuitable for participation in the clinical study.
- History or presence of:
- risk factors for Torsades de Pointes (e.g., heart failure, cardiomyopathy, or family history of Long QT Syndrome);
- sick sinus syndrome, Mobitz 2second, or third-degree atrioventricular block, myocardial infarction, pulmonary congestion, cardiac arrhythmia, prolonged QT interval QTc>450 male/470 female), or conduction abnormalities;
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- repeated or frequent syncope or vasovagal episodes;
- hypertension, angina, bradycardia, or severe peripheral arterial circulatory disorders.
- Subjects with serum creatinine clearance below 90 mL/min.
- Subject has history of alcohol and/or illicit drug abuse within 2 years prior to the first dose of study drug.
- Subject has positive test for Hepatitis B surface antigen, Hepatitis C antibody or human immunodeficiency virus antibody at the screening visit.
- Subject has positive urine drug (e.g., cocaine, amphetamines, barbiturates, opiates, benzodiazepines, cannabinoids), alcohol or cotinine test at the Screening Visit or Day -2. Consumption of alcohol and alcohol-containing foods, medications or beverages 48 hours prior to the screening visit.
- Female subjects are breastfeeding or female subjects with a positive serum pregnancy test at the Screening Visit or positive urine pregnancy test on Day -2.
- Has had surgery or any medical condition which may affect the absorption, distribution, metabolism, or elimination of the study drugs within 6 months prior to the first dose, in the opinion of the Principal Investigator.
- Plasma donation within 7 days prior to the first dose of study drug.
- Subject has donated > 500 mL blood or blood products within 2 months (56 days) prior to admission.
- Subject is unwilling to avoid consumption of coffee and caffeine containing beverages from 48 hours prior to admission until discharge from the clinical site.
- Use of any prescription or over-the-counter medication including antacids, herbal remedies, or vitamin or nutritional supplements (especially those containing biotin, magnesium, aluminum, iron, or zinc), excluding contraceptive pill, and intermittent use of paracetamol, ibuprofen, or acetylic salicylic acid within 14 days prior to Screening and throughout the study, unless approved by both the Investigator and the Sponsor.
- Subject has used an investigational drug, or device within 3 months or 5 half-lives of the investigational drug (whichever is longer) prior to Screening.
- Participation in a previous clinical trial where subject received MD1003.
- Subject has been on a diet incompatible with the on study diet (including an extreme diet which resulted in a significant weight change for whatever reason), in the opinion of the Principal Investigator, within the 28 days prior to the first dose of study drug, and throughout the study.
- Subject is unwilling to abstain from vigorous exercise from 48 hours prior to admission until the End of Study Visit.
- Subject has a history of hypersensitivity to the study drug or any of the excipients (incl. lactose), or to medicinal products with similar chemical structures.
- Subject is unlikely to comply with the protocol requirements, instructions and study related restrictions; e.g., uncooperative attitude, inability to return for follow-up visits and improbability of completing the clinical study.
- Vulnerable subjects defined as individuals whose willingness to volunteer in a clinical study may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate (e.g., persons in detention, minors and those incapable of giving consent).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Parexel Early Phase Clinical Unit London
London, Middlesex, HA13UJ
Muna Albayaty, MD, 44 1895 614592, muna.albayaty@parexel.com
Suresh Babu, 44 1895614736, Suresh.Babu@parexel.com
About this study
Official title: A Phase 1, Single-Center, Double-Blind, Randomized, Placebo- and Positive Controlled, Double-Dummy, Parallel-Group, Repeated Dose Study With a Nested Cross-Over Comparison Between Moxifloxacin and Placebo to Evaluate the Effect of MD1003 on Cardiac Repolarization in Healthy Adult Subjects
This is a Phase 1, single-center, double-blind, randomized, placebo- and positive controlled, double-dummy, parallel-group, repeated-dose study with a nested cross-over comparison between moxifloxacin and placebo to evaluate the effect of MD1003 on cardiac repolarization in healthy adult subjects.
The planned enrollment is approximately 64 subjects randomized in a ratio of 1:1 to 2main groups. Subjects in Group B will be further randomized to Subgroups B1 and B2 in a ratio of 1:1.
Read the detailed description
This study is designed as a definitive evaluation of the potential of MD1003 and its major metabolites to have a threshold effect on cardiac repolarization, as detected by QT/QTc prolongation. The design is aligned with the recommendations for evaluation of QT/QTc interval prolongation outlined in the International Council for Harmonization (ICH) E14 guidance.
This is a Phase 1, single-center, double-blind, randomized, placebo- and positive controlled, double-dummy, parallel-group, repeated-dose study with a nested cross-over comparison between moxifloxacin and placebo to evaluate the effect of MD1003 on cardiac repolarization in healthy adult subjects.
A total of 64 subjects will be enrolled in the clinical study according to the inclusion/exclusion criteria. The study consists of two main groups with 32 subjects per dose group. All subjects will receive placebo for MD1003 on Day -1. Subjects in Group A will receive MD1003 (biotin) 1200 mg and placebo for moxifloxacin on Day 1, MD1003 (biotin) 1200 mg from Day 2 through Day 8 and placebo for moxifloxacin on Day 9. Subjects in Group B will be further randomized to Subgroup B1 (16 subjects) receiving moxifloxacin 400 mg and placebo for MD1003 on Day 1, placebo for MD1003 from Day 2 through Day 8 and placebo for moxifloxacin on Day 9. Subgroup B2 (16 subjects) will receive placebo for moxifloxacin and placebo for MD1003 on Day 1, placebo for MD1003 from Day 2 through Day 8 and moxifloxacin 400 mg on Day 9.
- Conditions
- Healthy Volunteers
- Being tested
- MD1003, Moxifloxacin 400mg, Placebo for MD1003, Placebo for moxifloxacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MD1003Drug
Also called Biotin
Group A: Daily dose of 1200 mg of MD1003 from Day 1 to Day 8
Moxifloxacin 400mgDrug
Also called Moxifloxacin
Group B1: Moxifloxacin 400 mg on Day 1 Group B2: Moxifloxacin 400 mg on Day 9
Placebo for MD1003Drug
Group A: Placebo for MD1003 on Day -1 Group B1: Placebo for MD1003 on Day -1 Group B2: Placebo for MD1003 on Day -1
Placebo for moxifloxacinDrug
Group A: Placebo for moxifloxacin on Day 1 and Day 9 Group B1: Placebo for moxifloxacin on Day 9 Group B2: Placebo for moxifloxacin on Day 1
| Study group | Role | What they receive |
|---|---|---|
| Group A-MD1003 | Experimental | Group A=32 subjects Placebo for MD1003 on Day -1. Daily dose of 1200 mg of MD1003 from Day 1 to Day 8 Placebo for moxifloxacin on Day 1 and Day 9 Receives: Drug: MD1003; Drug: Placebo for MD1003; Drug: Placebo for moxifloxacin |
| Group B-Moxifloxacin | Active comparator | Subjects in Group B will be further randomized to Subgroups B1 and B2 in a ratio of 1:1.
Subgroup B1: 16 subjects Placebo for MD1003 on Day -1 Placebo for MD1003 from Day 1 to Day 8 Moxifloxacin 400 mg on Day 1 and Placebo for moxifloxacin on Day 9 Subgroup B2: 16 subjects Placebo for MD1003 on Day -1 Placebo for MD1003 from Day 1 to Day 8 Placebo for moxifloxacin on Day 1 and Moxifloxacin 400 mg on Day 9 Receives: Drug: Moxifloxacin 400mg; Drug: Placebo for MD1003; Drug: Placebo for moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline QTcF (ΔQTcF) on Day 8 (after 8 days of 1200 mg MD1003)
Replicate electrocardiograms (ECGs) (10 ECG replicates) for the determination of ΔQTc interval will be extracted from the continuous digital 12-lead ECG recording in the 5 minutes prior to dosing and then at 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose on D-1 and D8
Measured: 9 days
Secondary outcomes (12)
Placebo-corrected change from baseline QTcF (ΔΔQTcF) on Day 8 (after 8 days of 1200 mg MD1003)
Replicate electrocardiograms (ECGs) (10 ECG replicates) for the determination of ΔΔQTc interval will be extracted from the continuous digital 12-lead ECG recording in the 5 minutes prior to dosing and then at 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose on D-1 and D8
Measured: 9 days
Change from baseline of Heart Rate (ΔHR) on Day 8 (after 8 days of 1200 mg MD1003)
Replicate electrocardiograms (ECGs) (10 ECG replicates) for the determination of ΔHR interval will be extracted from the continuous digital 12-lead ECG recording in the 5 minutes prior to dosing and then at 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose on D-1 and D8
Measured: 9 days
Placebo-corrected, change from baseline of Heart Rate (ΔΔHR) on Day 8 (after 8 days of 1200 mg MD1003)
Replicate electrocardiograms (ECGs) (10 ECG replicates) for the determination of ΔΔHR interval will be extracted from the continuous digital 12-lead ECG recording in the 5 minutes prior to dosing and then at 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose on D-1 and D8
Measured: 9 days
Change from baseline of Pulse Rate (ΔPR) on Day 8 (after 8 days of 1200 mg MD1003)
Measurement of PR will be performed manually in 3 of the 9 ECG replicates at each timepoint at 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose on D1 and D8
Measured: 8 days
Placebo-corrected, change from baseline of Pulse Rate (ΔΔPR) on Day 8 (after 8 days of 1200 mg MD1003)
Measurement of PR will be performed manually in 3 of the 9 ECG replicates at each timepoint at 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose on D1 and D8
Measured: 8 days
Change from baseline of QRS interval (ΔQRS) on Day 8 (after 8 days of 1200 mg MD1003)
Measurement of QRS interval will be performed manually in 3 of the 9 ECG replicates at each timepoint at 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose on D1 and D8
Measured: 8 days
Placebo-corrected, change from baseline of QRS interval (ΔΔQRS) on Day 8 (after 8 days of 1200 mg MD1003)
Measurement of QRS interval will be performed manually in 3 of the 9 ECG replicates at each timepoint at 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose on D1 and D8
Measured: 8 days
T-wave morphology
Frequency of treatment emergent changes in T-wave morphology. Measurement of T-wave morphology will be performed manually in 3 of the 9 ECG replicates at each timepoint at 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose on D1 and D8
Measured: 8 days
U-waves presence
Frequency of treatment emergent changes in U-waves presence. Measurement of U-waves presence will be performed manually in 3 of the 9 ECG replicates at each timepoint at 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose on D1 and D8
Measured: 8 days
Maximum plasma concentrations (Cmax) of MD1003 will be measured at D1 and D8 post-dose (after 8 days of dosing of 1200mg of MD1003)
The measured individual plasma concentration at pre-dose then at 0.5, 1, 2, 3, 4, 8,12, 24 hours (D1 and D8) post-dose will be used to directly obtain Cmax. Unit: ng/ml.
Measured: 8 days
Area under the curve (AUC max) of MD1003 will be measured at D1 and D8 post-dose (after 8 days of dosing of 1200mg of MD1003)
AUC max at pre-dose then at 0.5, 1, 2, 3, 4, 8,12, 24 hours (D1 and D8) post-dose will be used to directly obtain AUC max. Unit: ng.h/ml
Measured: 8 days
Time for maximum plasma concentration (tmax) of MD1003 will be determined directly from the concentration-time profile
tmax will be determined directly from the concentration-time profile. Unit: hour
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start11 Nov 2019
- Primary completion5 Mar 2020 (estimated)
- Study completion5 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Model description
- Double-Blind, Randomized, Placebo- and Positive Controlled, Double-Dummy, Parallel-Group, Repeated-Dose Study with a Nested Cross-Over Comparison Between Moxifloxacin and Placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MedDay Pharmaceuticals SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel, ERT: Clinical Trial Technology Solutions
- Responsible party
- Sponsor
- Investigators
- Muna Albayaty, MD, Principal investigator, Parexel Early Phase Clinical Unit London,Northwick Park Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04168723
- Sponsor's protocol ID
- MD1003CT2019-04TQT2
- Acronym
- TQT2
- Status last verified
- Feb 2020
- First submitted
- 8 Nov 2019
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-Center, Double-Blind, Randomized, Placebo- and Positive Controlled, Double-Dummy, Parallel-Group, Repeated Dose Study With a Nested Cross-Over Comparison Between Moxifloxacin and Placebo to Evaluate the Effect of MD1003 on Cardiac Repolarization in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT04168723
- Acronym / sponsor ID
- TQT2 / MD1003CT2019-04TQT2
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- MedDay Pharmaceuticals SAIndustry (pharma, biotech, devices)
- Collaborators
- Parexel, ERT: Clinical Trial Technology Solutions
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 5 Mar 2020 (estimated)
- Study completion
- 5 Mar 2020 (estimated)
- First posted
- 19 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1, single-center, double-blind, randomized, placebo- and positive controlled, double-dummy, parallel-group, repeated-dose study with a nested cross-over comparison between moxifloxacin and placebo to evaluate the effect of MD1003 on cardiac repolarization in healthy adult subjects.
The planned enrollment is approximately 64 subjects randomized in a ratio of 1:1 to 2main groups. Subjects in Group B will be further randomized to Subgroups B1 and B2 in a ratio of 1:1.
Detailed description
This study is designed as a definitive evaluation of the potential of MD1003 and its major metabolites to have a threshold effect on cardiac repolarization, as detected by QT/QTc prolongation. The design is aligned with the recommendations for evaluation of QT/QTc interval prolongation outlined in the International Council for Harmonization (ICH) E14 guidance.
This is a Phase 1, single-center, double-blind, randomized, placebo- and positive controlled, double-dummy, parallel-group, repeated-dose study with a nested cross-over comparison between moxifloxacin and placebo to evaluate the effect of MD1003 on cardiac repolarization in healthy adult subjects.
A total of 64 subjects will be enrolled in the clinical study according to the inclusion/exclusion criteria. The study consists of two main groups with 32 subjects per dose group. All subjects will receive placebo for MD1003 on Day -1. Subjects in Group A will receive MD1003 (biotin) 1200 mg and placebo for moxifloxacin on Day 1, MD1003 (biotin) 1200 mg from Day 2 through Day 8 and placebo for moxifloxacin on Day 9. Subjects in Group B will be further randomized to Subgroup B1 (16 subjects) receiving moxifloxacin 400 mg and placebo for MD1003 on Day 1, placebo for MD1003 from Day 2 through Day 8 and placebo for moxifloxacin on Day 9. Subgroup B2 (16 subjects) will receive placebo for moxifloxacin and placebo for MD1003 on Day 1, placebo for MD1003 from Day 2 through Day 8 and moxifloxacin 400 mg on Day 9.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-Blind, Randomized, Placebo- and Positive Controlled, Double-Dummy, Parallel-Group, Repeated-Dose Study with a Nested Cross-Over Comparison Between Moxifloxacin and Placebo
| Arm | Type | Receives |
|---|---|---|
| Group A-MD1003 | Experimental | Drug: MD1003, Drug: Placebo for MD1003, Drug: Placebo for moxifloxacinGroup A=32 subjects Placebo for MD1003 on Day -1. Daily dose of 1200 mg of MD1003 from Day 1 to Day 8 Placebo for moxifloxacin on Day 1 and Day 9 |
| Group B-Moxifloxacin | Active comparator | Drug: Moxifloxacin 400mg, Drug: Placebo for MD1003, Drug: Placebo for moxifloxacinSubjects in Group B will be further randomized to Subgroups B1 and B2 in a ratio of 1:1. Subgroup B1: 16 subjects Placebo for MD1003 on Day -1 Placebo for MD1003 from Day 1 to Day 8 Moxifloxacin 400 mg on Day 1 and Placebo for moxifloxacin on Day 9 Subgroup B2: 16 subjects Placebo for MD1003 on Day -1 Placebo for MD1003 from Day 1 to Day 8 Placebo for moxifloxacin on Day 1 and Moxifloxacin 400 mg on Day 9 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- Subject voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent form prior to performing any of the Screening Visit procedures.
- Males and females between 18 to 55 years of age, inclusive, at the Screening Visit.
- Female subjects of childbearing potential must not be planning to become pregnant, must not be breastfeeding, and must have a negative serum pregnancy test at Screening and negative urine pregnancy test on Day-2.
- Sexually active female subjects of childbearing potential (i.e. women who are not post-menopausal [12 months of spontaneous amenorrhea without an alternative medical cause and follicle stimulating hormone (FSH) levels in the post-menopausal range for the laboratory involved] or who have not had a documented hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) and all male subjects (who have not been surgically sterilized by documented vasectomy) must agree to use highly effective methods of contraception during the study and for 8 weeks after the last dose of study drug. Please refer to Section 5.4.4 for acceptable methods of contraception.
- Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to the screening.
Key exclusion criteria (25 listed)
- Subject has clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological or psychiatric disorder(s) as determined by the Principal Investigator or designee.
- Subject has any disorder that would interfere with the absorption, distribution, metabolism or excretion of drugs.
- Subject has any concurrent disease or condition that, in the opinion of the Principal Investigator, would make the subject unsuitable for participation in the clinical study.
- History or presence of:
- Subjects with serum creatinine clearance below 90 mL/min.
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 |
|---|---|---|
| MD1003Also: BiotinGroup A: Daily dose of 1200 mg of MD1003 from Day 1 to Day 8 | Drug | Group A-MD1003 |
| Moxifloxacin 400mgAlso: MoxifloxacinGroup B1: Moxifloxacin 400 mg on Day 1 Group B2: Moxifloxacin 400 mg on Day 9 | Drug | Group B-Moxifloxacin |
| Placebo for MD1003Group A: Placebo for MD1003 on Day -1 Group B1: Placebo for MD1003 on Day -1 Group B2: Placebo for MD1003 on Day -1 | Drug | Group A-MD1003, Group B-Moxifloxacin |
| Placebo for moxifloxacinGroup A: Placebo for moxifloxacin on Day 1 and Day 9 Group B1: Placebo for moxifloxacin on Day 9 Group B2: Placebo for moxifloxacin on Day 1 | Drug | Group A-MD1003, Group B-Moxifloxacin |
Primary outcome
Change from baseline QTcF (ΔQTcF) on Day 8 (after 8 days of 1200 mg MD1003)
Time frame: 9 days
Replicate electrocardiograms (ECGs) (10 ECG replicates) for the determination of ΔQTc interval will be extracted from the continuous digital 12-lead ECG recording in the 5 minutes prior to dosing and then at 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose on D-1 and D8
12 secondary outcomes
Placebo-corrected change from baseline QTcF (ΔΔQTcF) on Day 8 (after 8 days of 1200 mg MD1003)
Time frame: 9 days
Change from baseline of Heart Rate (ΔHR) on Day 8 (after 8 days of 1200 mg MD1003)
Time frame: 9 days
Placebo-corrected, change from baseline of Heart Rate (ΔΔHR) on Day 8 (after 8 days of 1200 mg MD1003)
Time frame: 9 days
Change from baseline of Pulse Rate (ΔPR) on Day 8 (after 8 days of 1200 mg MD1003)
Time frame: 8 days
Placebo-corrected, change from baseline of Pulse Rate (ΔΔPR) on Day 8 (after 8 days of 1200 mg MD1003)
Time frame: 8 days
Change from baseline of QRS interval (ΔQRS) on Day 8 (after 8 days of 1200 mg MD1003)
Time frame: 8 days
Placebo-corrected, change from baseline of QRS interval (ΔΔQRS) on Day 8 (after 8 days of 1200 mg MD1003)
Time frame: 8 days
T-wave morphology
Time frame: 8 days
U-waves presence
Time frame: 8 days
Maximum plasma concentrations (Cmax) of MD1003 will be measured at D1 and D8 post-dose (after 8 days of dosing of 1200mg of MD1003)
Time frame: 8 days
Area under the curve (AUC max) of MD1003 will be measured at D1 and D8 post-dose (after 8 days of dosing of 1200mg of MD1003)
Time frame: 8 days
Time for maximum plasma concentration (tmax) of MD1003 will be determined directly from the concentration-time profile
Time frame: 8 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- 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.
Muna Albayaty, MD principal investigator
Parexel Early Phase Clinical Unit London,Northwick Park Hospital
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 MD1003 and Moxifloxacin 400mg in people with Healthy Volunteers, run by MedDay Pharmaceuticals SA 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 19 inclusion and 25 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: status not confirmed, as of the sponsor's last update on 20 Feb 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdelkarim Bendarraz (+33 1 80 40 14 39, Abdabdelkarim.bendarraz@medday-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline QTcF (ΔQTcF) on Day 8 (after 8 days of 1200 mg MD1003) (time frame: 9 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2020.