NCT02387580

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 13, 2015

Completed
19 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
8 months until next milestone

Results Posted

Study results publicly available

January 14, 2016

Completed
Last Updated

February 8, 2016

Status Verified

January 1, 2016

Enrollment Period

2 months

First QC Date

March 5, 2015

Results QC Date

December 9, 2015

Last Update Submit

January 13, 2016

Conditions

Malaria

Keywords

MalariaBioavailabilityFormulation

Outcome Measures

Primary Outcomes (4)

  • OZ439 Cmax

    OZ439 Maximum observed concentration

    Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours post-dose

  • OZ439 AUC(0-168 h)

    OZ439 Area under the plasma concentration (AUC) versus time curve

    pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours post-dose

  • Piperaquine Cmax

    Piperaquine Maximum observed concentration

    Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours and Day36 post-dose

  • Piperaquine AUC(0-168 h)

    PQP Area under the plasma concentration versus time curve

    Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours and Day36 post-dose

Study Arms (6)

Regimen A: OZ439 + TPGS and PQP

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

Drug: OZ439 + TPGSDrug: PQP

Regimen B: OZ439 Prototype 1 and PQP - 110mL

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

Drug: OZ439 Prototype 1Drug: PQP

Regimen C: OZ439 Prototype 3 and PQP - 110mL

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

Drug: OZ439 Prototype 3Drug: PQP

Regimen D: OZ439 + TPGS and PQP

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

Drug: OZ439 + TPGSDrug: PQP

Regimen E: OZ439 Prototype 1 or 3 and PQP - XmL

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

Drug: OZ439 Prototype 1Drug: PQP

Regimen F: OZ439 Prototype 1 or 3 and PQP - XmL

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

Drug: OZ439 Prototype 3Drug: PQP

Interventions

OZ439 + TPGSDRUG
Also known as: 800 mg OZ439 + TPGS Reference Treatment
Regimen A: OZ439 + TPGS and PQPRegimen D: OZ439 + TPGS and PQP
OZ439 Prototype 1DRUG
Also known as: OZ439 Granules Prototype 1 Granules Formulation
Regimen B: OZ439 Prototype 1 and PQP - 110mLRegimen E: OZ439 Prototype 1 or 3 and PQP - XmL
OZ439 Prototype 3DRUG
Also known as: OZ439 Granules Prototype 3 Granules Formulation
Regimen C: OZ439 Prototype 3 and PQP - 110mLRegimen F: OZ439 Prototype 1 or 3 and PQP - XmL
PQPDRUG
Also known as: PQP 960 mg tablets
Regimen A: OZ439 + TPGS and PQPRegimen B: OZ439 Prototype 1 and PQP - 110mLRegimen C: OZ439 Prototype 3 and PQP - 110mLRegimen D: OZ439 + TPGS and PQPRegimen E: OZ439 Prototype 1 or 3 and PQP - XmLRegimen F: OZ439 Prototype 1 or 3 and PQP - XmL

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Quotient Clinical

Nottingham, Nottinghamshire, NG11 6JS, United Kingdom

Location

MeSH Terms

Conditions

Malaria

Interventions

artefenomeltocophersolan

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Results Point of Contact

Title
Fiona Macintyre PhD
Organization
Medicines for Malaria Venture (MMV)
Macintyref@mv.org
+41 22 555 0319

Study Officials

  • Fiona Macintyre, PhD

    Medicines for Malaria Ventire

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2015

First Posted

March 13, 2015

Study Start

April 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

February 8, 2016

Results First Posted

January 14, 2016

Record last verified: 2016-01

Locations

GB(1)