Trial Outcomes & Findings for OZ439 PhIIa Study in Plasmodium Falciparum: Extended Observation (NCT NCT01713621)

NCT ID: NCT01713621

Last Updated: 2017-04-14

Results Overview

The estimated MIC and MPC were derived from the fitted parasitaemia concentration and PK/PD relationship.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

25 participants

Primary outcome timeframe

up to 28 days

Results posted on

2017-04-14

Participant Flow

Patients were recruited and followed up over 28 days in four clinics in Thailand from April 2013 to April 2015.

Participant milestones

Participant milestones
Measure	OZ439 100mg Single dose of 100mg of OZ439 administered as an oral suspension	OZ439 500mg Single dose of 500mg of OZ439 administered as an oral suspension
Overall Study STARTED	8	17
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	7	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

OZ439 PhIIa Study in Plasmodium Falciparum: Extended Observation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OZ439 100mg n=8 Participants Single dose of 100mg of OZ439 administered as an oral suspension	OZ439 500mg n=17 Participants Single dose of 500mg of OZ439 administered as an oral suspension	Total n=25 Participants Total of all reporting groups
Age, Continuous	37 years STANDARD_DEVIATION 12.44 • n=93 Participants	34 years STANDARD_DEVIATION 10.49 • n=4 Participants	35 years STANDARD_DEVIATION 10.98 • n=27 Participants
Sex: Female, Male Female	1 Participants n=93 Participants	3 Participants n=4 Participants	4 Participants n=27 Participants
Sex: Female, Male Male	7 Participants n=93 Participants	14 Participants n=4 Participants	21 Participants n=27 Participants
Race/Ethnicity, Customized Asian	8 Participants n=93 Participants	17 Participants n=4 Participants	25 Participants n=27 Participants
Region of Enrollment Thailand	8 participants n=93 Participants	17 participants n=4 Participants	25 participants n=27 Participants

PRIMARY outcome

Timeframe: up to 28 days

Population: Model predicted MIC and MPC

The estimated MIC and MPC were derived from the fitted parasitaemia concentration and PK/PD relationship.

Outcome measures

Outcome measures
Measure	OZ439 100mg n=7 Participants Single dose of 100mg of OZ439 administered as an oral suspension	OZ439 500mg n=15 Participants Single dose of 500mg of OZ439 administered as an oral suspension
Minimum Inhibitory Concentration (MIC) and Minimum Parasiticidal Concentration (MPC) Model predicted MIC	2.4 ng/Ml Standard Deviation 3.5	4.1 ng/Ml Standard Deviation 5
Minimum Inhibitory Concentration (MIC) and Minimum Parasiticidal Concentration (MPC) Model predicted MPC	77 ng/Ml Standard Deviation 128	319 ng/Ml Standard Deviation 877

Adverse Events

OZ439 100mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

OZ439 500mg

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Dr. Jörg J. Möhrle

Medicines for Malaria Venture

Phone: +41 22 555 03 00

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	OZ439 100mg n=8 participants at risk Single dose of 100mg of OZ439 administered as an oral suspension	OZ439 500mg n=17 participants at risk Single dose of 500mg of OZ439 administered as an oral suspension
Gastrointestinal disorders vomiting	0.00% 0/8 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.	17.6% 3/17 • Number of events 3 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.
Gastrointestinal disorders Abdominal pain	12.5% 1/8 • Number of events 1 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.	5.9% 1/17 • Number of events 1 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.
Gastrointestinal disorders Diarrhoea	0.00% 0/8 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.	5.9% 1/17 • Number of events 1 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.
Gastrointestinal disorders Dyspepsia	0.00% 0/8 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.	5.9% 1/17 • Number of events 1 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.
Gastrointestinal disorders Nausea	0.00% 0/8 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.	5.9% 1/17 • Number of events 1 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.
Investigations ALANINE AMINOTRANSFERASE INCREASED	0.00% 0/8 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.	17.6% 3/17 • Number of events 3 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	0.00% 0/8 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.	11.8% 2/17 • Number of events 2 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.
Investigations BILIRUBIN CONJUGATED INCREASED	0.00% 0/8 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.	5.9% 1/17 • Number of events 1 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.
Investigations BLOOD BILIRUBIN INCREASED	0.00% 0/8 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.	5.9% 1/17 • Number of events 1 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.
Investigations HAEMOGLOBIN DECREASED	0.00% 0/8 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.	5.9% 1/17 • Number of events 1 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.
Investigations PLATELET COUNT DECREASED	0.00% 0/8 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.	5.9% 1/17 • Number of events 1 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.
Metabolism and nutrition disorders HYPERGLYCAEMIA	25.0% 2/8 • Number of events 2 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.	0.00% 0/17 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.
Metabolism and nutrition disorders DECREASED APPETITE	12.5% 1/8 • Number of events 1 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.	0.00% 0/17 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.
Metabolism and nutrition disorders HYPOKALAEMIA	0.00% 0/8 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.	5.9% 1/17 • Number of events 1 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.
Infections and infestations URINARY TRACT INFECTION	25.0% 2/8 • Number of events 2 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.	5.9% 1/17 • Number of events 1 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.
Nervous system disorders HEADACHE	25.0% 2/8 • Number of events 3 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.	0.00% 0/17 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.
Nervous system disorders DIZZINESS	12.5% 1/8 • Number of events 2 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.	0.00% 0/17 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.
Blood and lymphatic system disorders ANAEMIA	12.5% 1/8 • Number of events 1 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.	0.00% 0/17 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.
Blood and lymphatic system disorders LEUKOPENIA	0.00% 0/8 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.	5.9% 1/17 • Number of events 1 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.
Blood and lymphatic system disorders NEUTROPENIA	0.00% 0/8 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.	5.9% 1/17 • Number of events 1 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.
General disorders PYREXIA	25.0% 2/8 • Number of events 2 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.	0.00% 0/17 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.
Psychiatric disorders INSOMNIA	0.00% 0/8 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.	5.9% 1/17 • Number of events 1 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.
Psychiatric disorders SLEEP DISORDER	12.5% 1/8 • Number of events 1 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.	0.00% 0/17 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.
Respiratory, thoracic and mediastinal disorders COUGH	0.00% 0/8 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.	5.9% 1/17 • Number of events 1 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	12.5% 1/8 • Number of events 1 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.	0.00% 0/17 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.
Skin and subcutaneous tissue disorders PRURITUS	12.5% 1/8 • Number of events 1 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.	0.00% 0/17 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.
Skin and subcutaneous tissue disorders RASH	12.5% 1/8 • Number of events 1 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.	0.00% 0/17 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.
Skin and subcutaneous tissue disorders RASH MACULO-PAPULAR	0.00% 0/8 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.	5.9% 1/17 • Number of events 1 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.
Vascular disorders THROMBOPHLEBITIS	25.0% 2/8 • Number of events 2 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.	0.00% 0/17 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.
Cardiac disorders PALPITATIONS	0.00% 0/8 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.	5.9% 1/17 • Number of events 1 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.
Renal and urinary disorders LEUKOCYTURIA	0.00% 0/8 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.	5.9% 1/17 • Number of events 1 • Patients were assessed for AEs for the duration of the study during the extended observation period, until study discontinuation and the follow-up visit.