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MMV390048 Against Early Plasmodium Falciparum Blood Stage Infection in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02281344
Recruitment Status : Terminated (Inconsistent and unpredictable exposures were observed. Drug needed to be reformulated.)
First Posted : November 2, 2014
Results First Posted : June 9, 2020
Last Update Posted : June 9, 2020
Sponsor:
Collaborator:
Q-Pharm Pty Limited
Information provided by (Responsible Party):
Medicines for Malaria Venture

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Malaria, Falciparum
Intervention Drug: MMV390048 20mg
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cohort 1 MMV390048 20mg
Hide Arm/Group Description

Cohort 1 will receive a single, dose of 20mg MMV390048.

MMV390048 20mg: Supplied as a powder to be prepared as a suspension for oral use.

The study was conducted in one cohort (n=6) using a 20 mg dose of MMV390048 Powder In Bottle (PIB). Dose escalation was planned in a subsequent cohort, but due to the inconsistent pharmacokinetic profiles of the PIB formulation it was decided to reformulate the compound before proceeding with the study.

Period Title: Overall Study
Started 6
Completed 6
Not Completed 0
Arm/Group Title Cohort 1 MMV390048 20mg
Hide Arm/Group Description

Cohort 1 will receive a single, dose of 20mg MMV390048.

MMV390048 20mg: Supplied as a powder to be prepared as a suspension for oral use.

The study was conducted in one cohort (n=6) using a 20 mg dose of MMV390048 Powder In Bottle (PIB). Dose escalation was planned in a subsequent cohort, but due to the inconsistent pharmacokinetic profiles of the PIB formulation it was decided to reformulate the compound before proceeding with the study.

Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants
25.3  (4.03)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
0
   0.0%
Male
6
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
6
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 6 participants
24.50  (4.767)
1.Primary Outcome
Title MMV390048 Area Under the Plasma Concentration Versus Time Curve (AUClast) up to Day 21 Post-dose
Hide Description

Pharmacokinetic-pharmacodynamic relationship of MMV390048 on clearance of Plasmodium falciparum parasites from the blood in healthy participants following infection with blood stage parasites.

The area under the plasma concentration time curve from time zero to the last measured time point.

Time Frame At pre-dose, and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24 (D1), 30, 36, 48 (D2), 72 (D3), and 144 hours (D6) and Days 8, 10, 14, 18 and D21.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort 1 MMV390048 20mg
Hide Arm/Group Description:

Cohort 1 will receive a single, dose of 20mg MMV390048.

MMV390048 20mg: Supplied as a powder to be prepared as a suspension for oral use.

The study was conducted in one cohort (n=6) using a 20 mg dose of MMV390048 Powder In Bottle (PIB). Dose escalation was planned in a subsequent cohort, but due to the inconsistent pharmacokinetic profiles of the PIB formulation it was decided to reformulate the compound before proceeding with the study.

Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
9487  (2444)
2.Secondary Outcome
Title Parasite Reduction Rate (PRR) Following MMV390048 Treatment
Hide Description The clearance of malaria parasitemia by Polymerase Chain Reaction (PCR) measurement.
Time Frame From dosing up to Day 21 Post-dose
Outcome Measure Data Not Reported
3.Secondary Outcome
Title MMV390048 Maximum Plasma Concentration (Cmax)
Hide Description Maximum Plasma Concentration (Cmax) of MMV390048
Time Frame At pre-dose, and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24 (D1), 30, 36, 48 (D2), 72 (D3), and 144 hours (D6) and Days 8, 10, 14, 18 and D21.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort 1 MMV390048 20mg
Hide Arm/Group Description:

Cohort 1 will receive a single, dose of 20mg MMV390048.

MMV390048 20mg: Supplied as a powder to be prepared as a suspension for oral use.

The study was conducted in one cohort (n=6) using a 20 mg dose of MMV390048 Powder In Bottle (PIB). Dose escalation was planned in a subsequent cohort, but due to the inconsistent pharmacokinetic profiles of the PIB formulation it was decided to reformulate the compound before proceeding with the study.

Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: ng/mL
113  (43.8)
4.Secondary Outcome
Title MMV390048 Time to Maximum Plasma Concentration (Tmax)
Hide Description Time to Maximum Plasma Concentration (Tmax) of MMV390048
Time Frame From dosing up to Day 21 Post-dose
Outcome Measure Data Not Reported
Time Frame up to Day 21 Post-dose
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cohort 1 MMV390048 20mg
Hide Arm/Group Description

Cohort 1 will receive a single, dose of 20mg MMV390048.

MMV390048 20mg: Supplied as a powder to be prepared as a suspension for oral use.

The study was conducted in one cohort (n=6) using a 20 mg dose of MMV390048 Powder In Bottle (PIB). Dose escalation was planned in a subsequent cohort, but due to the inconsistent pharmacokinetic profiles of the PIB formulation it was decided to reformulate the compound before proceeding with the study.

All-Cause Mortality
Cohort 1 MMV390048 20mg
Affected / at Risk (%)
Total   0/6 (0.00%)    
Hide Serious Adverse Events
Cohort 1 MMV390048 20mg
Affected / at Risk (%) # Events
Total   0/6 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cohort 1 MMV390048 20mg
Affected / at Risk (%) # Events
Total   5/6 (83.33%)    
Gastrointestinal disorders   
Nausea *  1/6 (16.67%)  1
General disorders   
Chills *  1/6 (16.67%)  2
Hot flush *  1/6 (16.67%)  1
Hyperhidrosis *  1/6 (16.67%)  1
Pyrexia *  3/6 (50.00%)  7
Metabolism and nutrition disorders   
Decreased appetite *  2/6 (33.33%)  2
Musculoskeletal and connective tissue disorders   
Back pain *  1/6 (16.67%)  1
Nervous system disorders   
Headache *  3/6 (50.00%)  6
Paraesthesia *  1/6 (16.67%)  1
Respiratory, thoracic and mediastinal disorders   
Rinorrhea *  1/6 (16.67%)  1
*
Indicates events were collected by non-systematic assessment
Dose escalation was planned for more than 1 cohort, but due to inconsistent pharmacokinetic profiles the study was terminated.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Cristina Donini
Organization: Medicines for Malaria Venture
Phone: +41 22 555 0312
EMail: doninic@mmv.org
Layout table for additonal information
Responsible Party: Medicines for Malaria Venture
ClinicalTrials.gov Identifier: NCT02281344    
Other Study ID Numbers: QP14C11
First Submitted: October 30, 2014
First Posted: November 2, 2014
Results First Submitted: April 30, 2020
Results First Posted: June 9, 2020
Last Update Posted: June 9, 2020