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NCT04252430
RI Study to Assess and Compare the Pharmacokinetic Parameters of MD1003 in Renal Impaired Patients and Healthy Subjects
Phase 1 trial testing MD1003 in Healthy Volunteers in 24 participants. Terminated before completion.
17 March 2020
Quick facts
| Lead sponsor | MedDay Pharmaceuticals SA |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | other |
| Enrollment | 24 |
| Start date | 9 October 2019 |
| Primary completion | 17 March 2020 |
| Estimated completion | 17 March 2020 |
| Sites | 5 locations across France, Hungary |
Drugs / interventions tested
- MD1003 — full drug profile →
Conditions studied
- Healthy Volunteers — all drugs for Healthy Volunteers →
- Impaired Renal Function — all drugs for Impaired Renal Function →
Sponsor
MedDay Pharmaceuticals SA — full company profile →
Who can join
Adults 18 to 75, any sex, with Healthy Volunteers or Impaired Renal Function. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a Phase 1, multicentric, open-label,two arms to assess and compare the effect of single oral administration of MD1003 on the pharmacokinetic parameters in renal impaired patients and healthy subjects with normal renal function. The planned enrollment is 36 subjects (18 impaired patients and 18 healthy subjects).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04252430
- 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.
- NCT04168723 — TQT2 Study to Evaluate the Effect of MD1003 on Cardiac Repolarization in Healthy Adult Subjects · Phase 1 · unknown
- NCT04252417 — HI Study to Assess and Compare the Pharmacokinetic Parameters of MD1003 in Hepatic Impaired Patients and Healthy Subject · 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
- NCT04168723 — TQT2 Study to Evaluate the Effect of MD1003 on Cardiac Repolarization in Healthy Adult Subjects · Phase 1 · unknown
- NCT04252417 — HI Study to Assess and Compare the Pharmacokinetic Parameters of MD1003 in Hepatic Impaired Patients and Healthy Subject · 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 NCT04252430 (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: 13 May 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/NCT04252430.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing