Trial · NCT02573857

A Study to Characterise the Antimalarial and Transmission Blocking Activity of a Single Dose of DSM265 or OZ439 in Healthy Subjects With Induced Blood Stage Plasmodium Falciparum or Plasmodium Vivax Infection

NCT02573857, Phase 1, Phase 2, Terminated, Medicines for Malaria Venture; results first posted 2020-06-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Characterise the Antimalarial and Transmission Blocking Activity of a Single Dose of DSM265 or OZ439 in Healthy Subjects With Induced Blood Stage Plasmodium Falciparum or Plasmodium Vivax Infection. Trials, record NCT02573857. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02573857

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Characterise the Antimalarial and Transmission Blocking Activity of a Single Dose of DSM265 or OZ439 in Healthy Subjects With Induced Blood Stage Plasmodium Falciparum or Plasmodium Vivax Infection
NCT number: NCT02573857
Status: Terminated
Phases: Phase 1, Phase 2
Enrollment: 16 participants, actual
Lead sponsor: Medicines for Malaria Venture
Conditions: Malaria
Interventions: DSM265, OZ439
First posted: 2015-10-12
Last updated: 2020-06-05
Results first posted: 2020-06-05

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Efficacy (PRR) of DSM265 or OZ439	From baseline to 48 hours post antimalarial treatment	Efficacy of a single 400 mg dose of DSM265 or a 200mg dose of OZ439. The primary efficacy variable is parasite reduction ratio (PRR) of asexual parasites based on qPCR analysis of blood level parasitemia pre-dose and following administration of study drug. The parasite reduction ratio (PRR) provides an estimate of the efficacy of an antimalarial treatment and is the ratio of the parasite density between admission and 48 h post antimalarial treatment.
Primary	Efficacy of OZ439 on P. Vivax	From baseline to 48 hours post antimalarial treatment
Primary	Safety of DSM265 or OZ439 - Number of Adverse Events	From challenge inoculum (day 0) up to day 28 (+/-3 days)	Assessement of Adverse Events (AE) (unexpected toxicities, adverse events encountered during or after investigational drug administration)
Secondary	Gametocytemia Clearance With DSM265	From Drug administration up to day 28 (+/-3 days) following inoculum
Secondary	P. Vivax Transmission	From challenge inoculum (day 0) and up to day 28 (+/-3 days)
Secondary	Parasite Density (Parasite/ml) Assessed by qPCR	From From drug administration until Standard of Care administration, or up to day 28 (+/-3 days)
Secondary	Drug Concentration (PK) (ng/ml)	From From drug administration until Standard of Care administration, or up to day 28 (+/-3 days)

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Efficacy (PRR) of DSM265 or OZ439	From baseline to 48 hours post antimalarial treatment	Subject R104 in Cohort 1 was excluded from PRR analysis because parasitaemia was not observed in this subject.	PRR	MEAN
PRIMARY	Efficacy of OZ439 on P. Vivax	From baseline to 48 hours post antimalarial treatment	Redundant outcome measure. Results are reported in Outcome Measure 1 (Efficacy (PRR) of DSM265 or OZ439).
PRIMARY	Safety of DSM265 or OZ439 - Number of Adverse Events	From challenge inoculum (day 0) up to day 28 (+/-3 days)		Number of adverse events	NUMBER
SECONDARY	Gametocytemia Clearance With DSM265	From Drug administration up to day 28 (+/-3 days) following inoculum
SECONDARY	P. Vivax Transmission	From challenge inoculum (day 0) and up to day 28 (+/-3 days)
SECONDARY	Parasite Density (Parasite/ml) Assessed by qPCR	From From drug administration until Standard of Care administration, or up to day 28 (+/-3 days)
SECONDARY	Drug Concentration (PK) (ng/ml)	From From drug administration until Standard of Care administration, or up to day 28 (+/-3 days)

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Efficacy (PRR) of DSM265 or OZ439	DSM265 P. Falciparum	603	95% Confidence Interval 410 to 886	PRR
Efficacy (PRR) of DSM265 or OZ439	OZ439 P. Vivax	46	95% Confidence Interval 36 to 61	PRR
Safety of DSM265 or OZ439 - Number of Adverse Events	DSM265 P. Falciparum	53		Number of adverse events
Safety of DSM265 or OZ439 - Number of Adverse Events	OZ439 P. Vivax	107		Number of adverse events

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	DSM265 P. Falciparum	8
Overall Study	STARTED	OZ439 P. Vivax	8
Overall Study	COMPLETED	DSM265 P. Falciparum	8
Overall Study	COMPLETED	OZ439 P. Vivax	8
Overall Study	NOT COMPLETED	DSM265 P. Falciparum	0
Overall Study	NOT COMPLETED	OZ439 P. Vivax	0

Source ClinicalTrials.gov

Adverse events82

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Tachycardia	Cardiac disorders	DSM265 P. Falciparum	1	8	1
other	Tachycardia	Cardiac disorders	OZ439 P. Vivax	1	8	1
other	Abdominal discomfort	Gastrointestinal disorders	DSM265 P. Falciparum	0	8	0
other	Abdominal discomfort	Gastrointestinal disorders	OZ439 P. Vivax	2	8	6
other	Abdominal pain	Gastrointestinal disorders	DSM265 P. Falciparum	1	8	1
other	Abdominal pain	Gastrointestinal disorders	OZ439 P. Vivax	0	8	0
other	Abdominal tenderness	Gastrointestinal disorders	DSM265 P. Falciparum	1	8	1
other	Abdominal tenderness	Gastrointestinal disorders	OZ439 P. Vivax	0	8	0
other	Diarrhoea	Gastrointestinal disorders	DSM265 P. Falciparum	0	8	0
other	Diarrhoea	Gastrointestinal disorders	OZ439 P. Vivax	1	8	1

1 to 10 of 82Source ClinicalTrials.gov

See all 82 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	DSM265 P. Falciparum	0	8
Total, all-cause mortality	OZ439 P. Vivax	0	8
Total, other adverse events	DSM265 P. Falciparum	8	8
Total, other adverse events	OZ439 P. Vivax	8	8
Total, serious adverse events	DSM265 P. Falciparum	0	8
Total, serious adverse events	OZ439 P. Vivax	0	8

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
30858218	DERIVED	PubMed
32479608	DERIVED	PubMed
34179977	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
DSM265 P. Falciparum vs OZ439 P. Vivax: deaths from any cause	Trial comparisons
DSM265 P. Falciparum vs OZ439 P. Vivax: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02573857

GET https://conductscience.org/api/trials/v1/NCT02573857/events?page=2

API reference For AI assistants