Safety Tolerability & Pharmacokinetics of Co-administered Single Doses of OZ439 & Piperaquine to Healthy Subjects

NCT01660022 | Completed Phase 1 Results

• 1 other identifier: MMV_OZ439_12_002
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase I Study to investigate the safety, tolerability \& pharmacokinetics of co-administered single doses of OZ439 and Piperaquine to healthy subjects.

Conditions

Healthy

Keywords

Healthy; Volunteers

Outcome Measures

Primary Outcomes (6)

• OZ439 Cmax

  OZ439 Maximum concentration level

  Up to 168 hours post-dose

• Piperaquine Cmax

  Piperaquine Maximum concentration level

  Up to 1008 hours post-dose (Day 43)

• OZ439 AUC(0-168)

  Area under the plasma concentration versus time curve to 168 hours post-dose.

  Up to 168 hours post-dose

• OZ439 t1/2

  OZ439 Elimination half-life

  Up to 168 hours post-dose

• Piperaquine AUC(0-168)

  Piperaquine area under the plasma concentration versus time curve to 168 hours post-dose

  Up to 1008 hours post-dose (Day 43)

• Piperaquine t1/2

  Piperaquine Elimination half-life (t1/2).

  Up to 1008 hours post-dose (Day 43)

Study Arms (9)

OZ439 100mg

EXPERIMENTAL

100mg OZ439 single oral dose

Drug: 100mg OZ439 single oral dose

OZ439 100 mg + PQP 160mg

EXPERIMENTAL

100mg OZ439 single oral dose + 160mg Piperaquine single oral dose

Drug: 100mg OZ439 single oral dose; Drug: 160mg Piperaquine single oral dose

OZ439 100 mg + PQP 480mg

EXPERIMENTAL

100mg OZ439 single oral dose + 480mg Piperaquine single oral dose

Drug: 100mg OZ439 single oral dose; Drug: 480mg Piperaquine single oral dose

OZ439 100 mg + PQP 1440mg

EXPERIMENTAL

100mg OZ439 single oral dose + 1440mg Piperaquine single oral dose

Drug: 100mg OZ439 single oral dose; Drug: 1440mg Piperaquine single oral dose

OZ439 300mg

EXPERIMENTAL

300mg OZ439 single oral dose

Drug: 300 mg OZ439 single oral dose

OZ439 300 mg + PQP 1440mg

EXPERIMENTAL

300mg OZ439 single oral dose + 1440mg Piperaquine single oral dose

Drug: 300 mg OZ439 single oral dose; Drug: 1440mg Piperaquine single oral dose

OZ439 800mg

EXPERIMENTAL

800mg OZ439 single oral dose

Drug: 800 mg OZ439 single oral dose

OZ439 800 mg + PQP 1440mg

EXPERIMENTAL

800mg OZ439 single oral dose + 1440mg Piperaquine single oral dose

Drug: 1440mg Piperaquine single oral dose; Drug: 800 mg OZ439 single oral dose

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

100mg OZ439 single oral dose DRUG

100mg OZ439 oral suspension single dose

Also known as: OZ439

OZ439 100 mg + PQP 1440mg; OZ439 100 mg + PQP 160mg; OZ439 100 mg + PQP 480mg; OZ439 100mg

Placebo DRUG

Placebo

Placebo

300 mg OZ439 single oral dose DRUG

300mg OZ439 oral suspension single dose

Also known as: OZ439

OZ439 300 mg + PQP 1440mg; OZ439 300mg

160mg Piperaquine single oral dose DRUG

160 mg Piperaquine tablet

Also known as: Piperaquine

OZ439 100 mg + PQP 160mg

480mg Piperaquine single oral dose DRUG

480 mg Piperaquine tablet

Also known as: Piperaquine

OZ439 100 mg + PQP 480mg

1440mg Piperaquine single oral dose DRUG

1440 mg Piperaquine tablet

Also known as: Piperaquine

OZ439 100 mg + PQP 1440mg; OZ439 300 mg + PQP 1440mg; OZ439 800 mg + PQP 1440mg

800 mg OZ439 single oral dose DRUG

800mg OZ439 oral suspension single dose

Also known as: OZ439

OZ439 800 mg + PQP 1440mg; OZ439 800mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males \& females, 18-55 years old
• BMI 18 to 30kg/m2; total body weight \>50kg
• Healthy, determined by pre-study medical history, physical examination vital signs, 12 Lead ECG
• Females of non-childbearing potential.
• Males must agree to use a double barrier method of contraception
• Lab tests at screening within the reference ranges

You may not qualify if:

• Any condition that could affect drug absorption, e.g. gastrectomy, diarrhea
• Clinically relevant abnormalities in ECG
• Family history of sudden death or of congenital prolongation of QTc interval - History of symptomatic cardiac arrhythmias or with clinically relevant bradycardia
• Electrolyte disturbances
• History of drug or alcohol abuse, tobacco users
• Participation in evaluation of any drug for 3 months before the study
• Administration of ANY systemic medication/herbal product within 14 days of first dose of study drug.
• unaccustomed strenuous exercise within 7 days of any study visit
• Alcohol consumption within 24 hours of any study visit
• Consumption of any fruit juice or food containing grapefruit within 7 days
• Positive test for HIV-1, HBsAg or HCV
• Positive urine drug screen at Screening or admission
• Severe allergies/multiple drug allergies
• Volunteers who have donated blood or experienced significant blood loss within 90 days of screening
• Hemoglobin below lower limit of the reference range

Sponsors & Collaborators

• Medicines for Malaria Venture: lead
• Cross Research S.A.: collaborator

Study Sites (1)

Cross Research S.A.

Mendrisio, CH 6850, Switzerland

Location

MeSH Terms

Interventions

piperaquine

Results Point of Contact

• Title: Fiona Macintyre
• Organization: Medicines for Malaria Venture

macintyref@mmv.org

0041 22 555 0319

Study Officials

• Milko M Radicioni, MD PhD

  Cross Research S.A.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2012
• First Posted: August 8, 2012
• Study Start: September 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: January 21, 2015
• Results First Posted: January 21, 2015

Record last verified: 2015-01

Locations

CH (1)