Bioavailability Study of Oral OZ439 Prototype Formulations Administered With Piperaquine Phosphate (PQP)

NCT02083406 | Completed Phase 1 Results

• 1 other identifier: MMV_OZ439_13_007
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

A single dose study to investigate how different formulations of OZ439 co-administered with PQP tablest are processed by the body when taken without food

Conditions

Malaria

Keywords

Malaria; Bio-availability

Outcome Measures

Primary Outcomes (2)

• OZ439 AUC(0-168h)

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

  Up to 168 hours post-dose

• OZ439 Cmax

  OZ439 Maximum observed concentration

  Up to 168 hours post-dose

Secondary Outcomes (2)

• Piperaquine (PQ) AUC(0-168h)

  Up to 168h post-dose

• PQ Cmax

  Up to 168h post-dose

Study Arms (3)

Treatment A: OZ439 Prototype 1

EXPERIMENTAL

800mg OZ439 prototype formulation 1 and 960mg PQP single doses

Drug: 800mg OZ439 prototype formulation 1; Drug: 960mg PQP

Treatment B: OZ439 Prototype 2

EXPERIMENTAL

800mg OZ439 prototype formulation 2 and 960mg PQP single doses

Drug: 800mg OZ439 prototype formulation 2; Drug: 960mg PQP

Treatment C: OZ439 Prototype 3

EXPERIMENTAL

800mg OZ439 prototype formulation 3 and 960mg PQP single doses

Drug: 800mg OZ439 prototype formulation 3; Drug: 960mg PQP

Interventions

800mg OZ439 prototype formulation 1 DRUG

Also known as: Treatment A

Treatment A: OZ439 Prototype 1

800mg OZ439 prototype formulation 2 DRUG

Also known as: Treatment B

Treatment B: OZ439 Prototype 2

800mg OZ439 prototype formulation 3 DRUG

Also known as: Treatment C

Treatment C: OZ439 Prototype 3

960mg PQP DRUG

Also known as: Piperqauine phosphate as powder in bottle

Treatment A: OZ439 Prototype 1; Treatment B: OZ439 Prototype 2; Treatment C: OZ439 Prototype 3

Eligibility Criteria

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

You may qualify if:

• Healthy males, or healthy females of non-childbearing potential ie surgically sterilised or post-menopausal (amenorrhoea for at least 1 year and confirmed by a follicle stimulating hormone result of ≥25 IU/mL
• Age 18 to 55 years of age
• Body mass index of 18.0 to 30.0 kg/m2 inclusive. Total body weight \>50 kg at screening
• Willing and able to communicate and participate in the whole study
• Must provide written informed consent
• Must agree to use an adequate method of contraception
• Must have liver function tests and haemoglobin within the laboratory reference range at screening and Day -1
• Must have heart trace measurements within the defined healthy limits at screening, Day -1 and pre-dose

You may not qualify if:

• Male subjects who have currently pregnant partners
• Evidence or history of clinically significant oncological, pulmonary, chronic respiratory, hepatic, cardiovascular, haematological, metabolic, neurological, immunological, nephrological, endocrine or psychiatric disease, or current infection
• Clinically relevant abnormalities in the heart trace including any degree of heart block, including asymptomatic bundle branch block
• 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
• Electrolyte disturbances, particularly hypokalemia, hypocalcaemia or hypomagnesaemia.
• Any condition that could possibly affect drug absorption, such as gastrectomy or diarrhoea
• History of post-antibiotic colitis
• History of any drug or alcohol abuse in the past 2 years prior to screening
• Subjects who have a breath carbon monoxide reading of greater than 10 ppm at screening will be excluded. Subjects who are tobacco users (including smokers and users of snuff, chewing tobacco and other nicotine or nicotine-containing products) must have stopped use within 90 days before screening.
• Receipt of an investigational drug or participation in another clinical research study within 90 days prior to drug administration.
• Subjects who are study site employees, or immediate family members of a study site or sponsor employee.
• Subjects who have previously been enrolled in this study
• amiodarone and hydroxychloroquine (210 days)
• monoclonal antibodies/ immunoglobulins/ other therapeutic proteins and experimental drugs for which the half-life is not known to the investigator (120 days)

Sponsors & Collaborators

• Medicines for Malaria Venture: lead
• Quotient Clinical: collaborator

Study Sites (1)

Quotient Clinical

Nottingham, Nottinghamshire, NG11 6JS, United Kingdom

Location

MeSH Terms

Conditions

Malaria

Interventions

Powders

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Fiona Macintyre, PhD
• Organization: Medicines for Malaria Venture (MMV)

macintyref@mmv.org

+41 22 555 0319

Study Officials

• Jo Collier, MBChB FFPM

  Quotient Clinical

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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 7, 2014
• First Posted: March 11, 2014
• Study Start: July 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: March 23, 2015
• Results First Posted: March 23, 2015

Record last verified: 2015-03

Locations

GB (1)