Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:21 AM
Study NCT ID:
NCT04866602
Status:
COMPLETED
Last Update Posted:
2022-05-05
First Post:
2021-04-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Atoguanil BA Study
Sponsor:
Medicines for Malaria Venture
Organization:
Study Overview
Official Title:
A Randomised, Open Label 2-period Crossover Study to Evaluate the Relative Bioavailability of Atoguanil Compared to Malarone® in Healthy Adult Participants in the Fed State
Status:
COMPLETED
Status Verified Date:
2022-05
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 trial aims to characterise the pharmacokinetic (PK) profile and estimate drug exposure from Atoguanil in comparison to Malarone®.
Detailed Description:
After being informed about the study and potential risks, all adult participants giving written informed consent will be screened within 30 days prior to entering the trial on Day -1 to determine eligibility for study entry. The trial will establish whether the PK profile of both atovaquone (ATV), proguanil (PG) and cycloguanil (CG) from Atoguanil is similar to Malarone® and whether exposure of ATV from Atoguanil indicates that at least a 2-fold reduction in ATV dose compared with Malarone® is feasible (i.e. that the bioavailability of ATV in Atoguanil is approximately double that of ATV in Malarone®).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: