Overview

This trial is active, not recruiting.

Condition malaria
Treatments oz439 + tpgs, oz439 prototype 1, oz439 prototype 3, pqp
Phase phase 1
Sponsor Medicines for Malaria Venture
Collaborator Quotient Clinical
Start date April 2015
End date June 2015
Trial size 48 participants
Trial identifier NCT02387580, MMV_OZ439_15_001

Summary

This is a single-centre, 2-part, randomised, single-dose parallel group study in healthy male subjects and female subjects of non-childbearing potential.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification bio-availability study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
oz439 + tpgs 800 mg OZ439 + TPGS Reference Treatment
pqp PQP 960 mg tablets
(Experimental)
800 mg OZ439 Prototype 1 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
oz439 prototype 1 OZ439 Granules Prototype 1 Granules Formulation
pqp PQP 960 mg tablets
(Experimental)
800 mg OZ439 Prototype 3 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
oz439 prototype 3 OZ439 Granules Prototype 3 Granules Formulation
pqp PQP 960 mg tablets
(Active Comparator)
800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
oz439 + tpgs 800 mg OZ439 + TPGS Reference Treatment
pqp PQP 960 mg tablets
(Experimental)
800 mg OZ439 Prototype 1 or 3 granules (oral suspension and rinse volume to be determined) and 960 mg (3 × 320 mg) PQP tablets
oz439 prototype 1 OZ439 Granules Prototype 1 Granules Formulation
pqp PQP 960 mg tablets
(Experimental)
800 mg OZ439 Prototype 1 or 3 granules (oral suspension and rinse volume to be determined) and 960 mg (3 × 320 mg) PQP tablets
oz439 prototype 3 OZ439 Granules Prototype 3 Granules Formulation
pqp PQP 960 mg tablets

Primary Outcomes

Measure
OZ439 Maximum observed concentration
time frame: Up to 168h postdose
OZ439 Area under the plasma concentration (AUC) versus time curve
time frame: Up to 168h postdose
PQP Maximum observed concentration
time frame: Up to 168h postdose
PQP Area under the plasma concentration versus time curve
time frame: Up to 168h postdose

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

Inclusion Criteria: - Healthy males, or healthy females of non-childbearing potential ie surgically sterilised or post-menopausal - Body mass index of 18.0 to 30.0 kg/m2 inclusive. Total body weight >50 kg at screening. - Must agree to use an adequate method of contraception. - Normal laboratory tests as judged by the Investigator. - Must have QTcF ≤450 ms, QTcB ≤450 ms for male subjects, QTcF ≤470 ms, QTcB ≤470 ms for female subjects and PR interval ≤200 ms for screening and pre-dose ECG measurements. Exclusion Criteria: - Male subjects who have currently pregnant partners or who have partners planning to be pregnant. - Evidence or history of clinically significant disease, or current infection.3. - Clinically relevant abnormalities in the ECG. - Family history of sudden death or of congenital prolongation of the QTc interval or known congenital prolongation of the QTc interval or any clinical condition known to prolong the QTc interval. - History of symptomatic cardiac arrhythmias or with clinically relevant bradycardia, heart rate ≤39 bpm. - Electrolyte disturbances, particularly hypokalaemia, hypocalcaemia or hypomagnesaemia. - History of any drug or alcohol abuse in the past 2 years prior to screening. - Receipt of an investigational drug or participation in another clinical research study within 90 days prior to drug administration. - Use of any prescription or non-prescription medications, vitamins, herbal supplements or dietary supplements, including protein supplements, within 14 days prior to the first dose of study drug. - Positive hepatitis B surface antigen, hepatitis C virus antibody or human immunodeficiency virus results. - Clinically significant abnormal biochemistry, haematology or urinalysis. - Positive urine drug screen result. - History of intolerance or hypersensitivity to PQP or any 4-aminoquinoline, or ascertained or presumptive hypersensitivity to the active principle and/or formulation ingredients; history of anaphylaxis to drugs or allergic reactions in general, that the investigator considers may affect the outcome of the study. - Presence or history of allergy requiring treatment; hayfever is allowed unless it is active. - Donation or loss of >400 mL of blood within 90 days prior to drug administration.

Additional Information

Official title A Phase I Bioavailability Study of Selected Oral Prototype Granule Formulations of OZ439 in Healthy Subjects, to Evaluate the Pharmacokinetics of OZ439 When Co-Administered With Piperaquine Phosphate Tablets in the Fasted State
Description Parts 1 and 2 will be randomised with 8 subjects receiving each regimen: Part 1: - Regimen A: Reference: 800 mg OZ439 + α-Tocopherol polyethylene glycol 1000 succinate (TPGS) granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets - Regimen B: Prototype 1: 800 mg OZ439 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets - Regimen C: Prototype 3: 800 mg OZ439 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets There will be an interim decision after Part 1 to determine the formulation prototypes and the oral suspension volume to be administered in Part 2. Part 2 - Regimen D: Reference: 800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets - Regimen E: Prototype 1 or 3: 800 mg OZ439 granules (oral suspension and rinse volume to be determined) and 960 mg (3 × 320 mg) PQP tablets - Regimen F: Prototype 1 or 3: 800 mg OZ439 granules (oral suspension and rinse volume to be determined) and 960 mg (3 × 320 mg) PQP tablets
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Medicines for Malaria Venture.