Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-02-22 @ 1:36 AM
Study NCT ID:
NCT02783833
Status:
COMPLETED
Last Update Posted:
2017-02-08
First Post:
2016-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MMV390048 and Its Antimalarial Activity Against Plasmodium Falciparum in Healthy Adult Subjects, Part B
Sponsor:
Medicines for Malaria Venture
Organization:
Study Overview
Official Title:
A Single Centre, Two-part, Phase I Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of Ascending Oral Doses of MMV390048 and Its Antimalarial Activity Against Plasmodium Falciparum in Healthy Adult Subjects
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pharmacodynamic profiling will also be studied to characterize the effects of MMV390048 on P. falciparum clearance kinetics in healthy subjects using the Induced Blood Stage Malaria (IBSM) challenge model to determine the minimum inhibitory concentration of MMV390048 for P. falciparum (Part B).
Detailed Description:
Pharmacodynamic profiling will also be studied to characterize the effects of MMV390048 on P. falciparum clearance kinetics in healthy subjects using the Induced Blood Stage Malaria (IBSM) challenge model to determine the minimum inhibitory concentration of MMV390048 for P. falciparum (Part B). An approximation of this concentration in healthy subjects will help to identify the optimal dose of MMV390048 for subsequent Phase 2 studies in patients. The challenge model will enable characterization of the exposure-response relationship for MMV390048 and will also provide data regarding the safety and tolerability of MMV390048 in a controlled disease-like setting.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: