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NCT04168723: TQT2
TQT2 Study to Evaluate the Effect of MD1003 on Cardiac Repolarization in Healthy Adult Subjects
Phase 1 trial testing MD1003 in Healthy Volunteers in 64 participants. Status unknown.
5 March 2020
Quick facts
| Lead sponsor | MedDay Pharmaceuticals SA |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | other |
| Enrollment | 64 |
| Start date | 11 November 2019 |
| Primary completion | 5 March 2020 |
| Estimated completion | 5 March 2020 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- MD1003 — full drug profile →
- Moxifloxacin 400mg — full drug profile →
- Placebo for MD1003 — full drug profile →
- Placebo for moxifloxacin — full drug profile →
Conditions studied
- Healthy Volunteers — all drugs for Healthy Volunteers →
Sponsor
MedDay Pharmaceuticals SA — full company profile →
Who can join
Adults 18 to 55, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04168723
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of MD1003
Trials testing the same drug.
- NCT04252417 — HI Study to Assess and Compare the Pharmacokinetic Parameters of MD1003 in Hepatic Impaired Patients and Healthy Subject · Phase 1 · terminated
- NCT04252430 — RI Study to Assess and Compare the Pharmacokinetic Parameters of MD1003 in Renal Impaired Patients and Healthy Subjects · Phase 1 · terminated
- NCT02967679 — SERENDEM : MD1003 in Patients Suffering From Demyelinating Neuropathies, an Open Label Pilot Study · Phase 2 · completed
Other recruiting trials for Healthy Volunteers
Currently open trials in the same condition.
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Other MedDay Pharmaceuticals SA trials
Trials by the same sponsor.
- NCT04223232 — Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-MD1003 in Healthy Male Subjects · Phase 1 · completed
- NCT04252417 — HI Study to Assess and Compare the Pharmacokinetic Parameters of MD1003 in Hepatic Impaired Patients and Healthy Subject · Phase 1 · terminated
- NCT04252430 — RI Study to Assess and Compare the Pharmacokinetic Parameters of MD1003 in Renal Impaired Patients and Healthy Subjects · Phase 1 · terminated
- NCT02967679 — SERENDEM : MD1003 in Patients Suffering From Demyelinating Neuropathies, an Open Label Pilot Study · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04168723 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by MedDay Pharmaceuticals SA
- Last refreshed: 20 February 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04168723.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing