Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-02-26 @ 12:35 AM
Study NCT ID:
NCT02783820
Status:
COMPLETED
Last Update Posted:
2020-06-11
First Post:
2016-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety, Tolerability and Pharmacokinetic Profile of Ascending Oral Doses of MMV390048, Part A
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:
2020-05
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:
This Phase I study will evaluate the safety, tolerability and pharmacokinetic properties of escalating single doses of reformulated MMV390048 when administered to healthy men and women of non-childbearing potential (WNCBP) under fasted conditions (Part A).
Detailed Description:
This Phase I study will evaluate the safety, tolerability and pharmacokinetic properties of escalating single doses of reformulated MMV390048 when administered to healthy men and women of non-childbearing potential (WNCBP) under fasted conditions (Part A).
Primary objectives:
• To evaluate the safety and tolerability of single ascending doses of MMV390048 administered orally to healthy subjects (men and WNCBP) under fasted conditions
Secondary objectives:
• To describe the pharmacokinetics of MMV390048 in healthy subjects (men and WNCBP) after single oral dose administration
Primary objectives:
• To evaluate the safety and tolerability of single ascending doses of MMV390048 administered orally to healthy subjects (men and WNCBP) under fasted conditions
Secondary objectives:
• To describe the pharmacokinetics of MMV390048 in healthy subjects (men and WNCBP) after single oral dose administration
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?: