Ignite Creation Date:
2024-05-06 @ 3:10 AM
Last Modification Date:
2024-10-26 @ 11:29 AM
Study NCT ID:
NCT02223871
Status:
COMPLETED
Last Update Posted:
2019-08-22
First Post:
2014-08-21
Brief Title:
Effect of ACT-451840 Against Early Plasmodium Falciparum Blood Stage Infection in Healthy Subjects
Sponsor:
Idorsia Pharmaceuticals Ltd
Organization:
Idorsia Pharmaceuticals Ltd
Study Overview
Official Title:
A Proof-of-concept Study to Assess the Effect of ACT-451840 Against Early Plasmodium Falciparum Blood Stage Infection in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2019-08
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 was a single-center study using induced blood stage malaria infection to characterize the activity of ACT-451840 against early Plasmodium falciparum blood stage infection
Detailed Description:
The primary objective of the study was to characterize the activity of ACT-451840 administered orally on clearance of Plasmodium falciparum blood stage parasites from the blood in healthy subjects The inoculum used for blood stage Plasmodium falciparum challenge BSPC contained an estimated 1800 viable parasite-infected erythrocytes diluted into 2 mL of normal saline for injection Blood was collected for malaria parasitemia assessment by polymerase chain reaction PCR Parasitemia 1000 parasitesmL indicated that the subjects should be treated with ACT-451840 If PCR counts were 5000 parasitesmL and symptomatic they were dosed within 24 hours Subsequent PCR blood sampling were performed prior to ACT-451840 dosing and at 2 4 8 12 16 20 24 30 36 48 60 72 84 96 120 144 hours post-dosing and then approximately times per week until 2 consecutive negative samples until Riamet rescue treatment and at the final visit
Study Oversight
Has Oversight DMC:
None
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?:
None