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NCT03490162 · ClinicalTrials.gov registry record · Phase 1
Safety and Pharmacokinetics Study of DM1157 to Treat Malaria
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
NCT03490162 is a Phase 1 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 50 participants.
The verdict
NCT03490162, a Phase 1 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
Study Summary
This is a phase 1 trial to evaluate the safety and pharmacokinetics of single and multiple ascending doses and effect of food on the pharmacokinetics of a novel antimalarial drug in healthy adults. The study will enroll 104 healthy volunteers, males and females, aged 18 to 45 years and will consists of 3 parts: Part 1, Single Ascending Dose (SAD); Part 2, Multiple Ascending Dose (MAD); and Part 3, Food Effect. Part 2 and Part 3 may be initiated after a Safety Monitoring Committee (SMC) review and approval of the of Part 1 safety data. Study duration will be 16 months with patient participation duration 14 days for SAD and Food Effect, and 18 days for MAD. The primary objectives of this study are to: 1) assess the safety and tolerability of single doses of DM1157 at levels ranging from 9 mg to 900 mg; 2) assess the safety and tolerability of DM1157 administered as single daily doses for 3 days at levels ranging from 150 mg to 900 mg; 3) assess the safety and tolerability of DM1157 administered with or without food.
Interventions
- OTHER Placebo
- DRUG DM1157
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2018-07-31 |
| Est. Completion | 2019-09-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03490162
The ClinicalTrials.gov registry entry for NCT03490162 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03490162 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03490162 about?
NCT03490162 is a clinical study titled "Safety and Pharmacokinetics Study of DM1157 to Treat Malaria". This is a phase 1 trial to evaluate the safety and pharmacokinetics of single and multiple ascending doses and effect of food on the pharmacokinetics of a novel antimalarial drug in healthy adults. The study will enroll 104 healthy volunteers, males and females, aged 18 to 45 years and will consists...
What is the current status of trial NCT03490162?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2018-07-31. Estimated completion is 2019-09-06.
What interventions are being tested in trial NCT03490162?
The interventions under investigation include: Placebo (OTHER), DM1157 (DRUG).
Who is sponsoring clinical trial NCT03490162?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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