NCT01860989

Brief Summary

This study will assess efficacy, safety , tolerability and PK in uncomplicated adult malaria patients with acute P. falciparum infection after single dose with KAE609 at 75 mg, 150mg, 225mg and 300mg/day

Trial Health

90
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2013

Shorter than P25 for phase_2

Geographic Reach
2 countries

4 active sites

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

May 21, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

September 3, 2015

Completed
Last Updated

September 10, 2015

Status Verified

September 1, 2015

Enrollment Period

1.1 years

First QC Date

May 21, 2013

Results QC Date

August 5, 2015

Last Update Submit

September 8, 2015

Conditions

Cure Rate

Keywords

parasitemia

Outcome Measures

Primary Outcomes (1)

  • 28-day Cure Rate

    28-day cure rate was measured by the endpoint of complete cure without recrudescence before Day 29. The primary variable of 28-day cure rate was defined as the proportion of patients with clearance of asexual parasitemia (by blood film) by day 6 of the study, and without subsequent recrudescence (by blood film).

    Day 28

Study Arms (4)

Cohort 1

EXPERIMENTAL

6-12 subjects with Plasmodium falciparum malaria will receive 75 mg KAE609 as a single dose

Drug: KAE609

Cohort 2

EXPERIMENTAL

6-12 subjects with Plasmodium falciparum malaria will receive 150 mg KAE609 as a single dose

Drug: KAE609

Cohort 3

EXPERIMENTAL

6 to 12 subjects with Plasmodium falciparum malaria will receive 225 mg KAE609 as a single dose

Drug: KAE609

Cohort4

EXPERIMENTAL

6- 12 subjects with Plasmodium falciparum malaria will receive 300 mg KAE609 as a single dose

Drug: KAE609

Interventions

KAE609DRUG

KAE609 75mg single dose

Cohort 1

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male and female patients aged 20 to 60 years
  • Presence of mono-infection of P. falciparum
  • Weight between 40 kg to 90 kg

You may not qualify if:

  • Patients with signs and symptoms of severe/complicated malaria
  • Mixed Plasmodium infection
  • Presence of other serious or chronic clinical condition requiring hospitalization.
  • Severe malnutrition
  • Significant chronic medical conditions which in the opinion of the investigator preclude enrollment into the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Novartis Investigative Site

Ratchabari, 70180, Thailand

Location

Novartis Investigative Site

Si Sa Ket, 33140, Thailand

Location

Novartis Investigative Site

Tak, 63140, Thailand

Location

Novartis Investigative Site

Hanoi, 10000, Vietnam

Location

MeSH Terms

Conditions

Parasitemia

Interventions

NITD 609

Condition Hierarchy (Ancestors)

Parasitic DiseasesInfectionsSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
862-778-8300

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2013

First Posted

May 23, 2013

Study Start

July 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

September 10, 2015

Results First Posted

September 3, 2015

Record last verified: 2015-09

Locations

VN(1)TH(3)