Efficacy, Safety, Tolerability and Pharmacokinetics of KAE609 in Adult Patients With Acute, Uncomplicated Plasmodium Falciparum or Vivax Malaria Mono-infection

NCT01524341 | Completed Phase 2

• 1 other identifier: CKAE609X2201
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 3

Brief Summary

This study will assess efficacy, safety , tolerability and PK in uncomplicated adult malaria patients with P. vivax or P. falciparum infection after 3 day dosing with KAE609 at 30 mg/day

Conditions

Malaria

Keywords

Acute malaria; KAE609

Outcome Measures

Primary Outcomes (1)

• Parasite clearance time

  Calculated based on parasite count in blood. In thin film, use actual WBCs/µl, of blood to calculate parasite density by using the following formula: parasites/µl= #parasites× actual WBC/#WBCs counted. In thick film, assume that there are 250 RBCs per HPF, RBC count from 8 HPF equal 2000 RBC, Use actual RBCs/µl blood to calculate parasite density by using the following formula: parasites/µl= # of parasites in 8HPF/2000)× actual RBC.

  From baseline to the time point when the blood parasite count is zero(up to a maximum of 5 days)

Secondary Outcomes (8)

• Number of participants with adverse events

  vital signs: Days 1 through 6; ECG: Days1, 2, 3; Labs: Days 2, 3, 5, study completion

• Area under the curve (AUC)0-24h on Day 1 and Day 3

  Day 1 and Day 3

• The accumulation ratio (Racc) (=AUC0-24h, day3/AUC0-24h, day1)

  Day 1 and Day 3

• Maximum concentration (Cmax) on Day 1 and Day 3

  Day 1 and Day 3

• Time to maximum concentration (Tmax) on Day 1 and Day 3

  Day 1 and Day 3

Study Arms (2)

Cohort 1

EXPERIMENTAL

10 subjects with Plasmodium vivax malaria will receive 30 mg KAE609 once a day for three days

Drug: KAE609

Cohort 2

EXPERIMENTAL

10 subjects with Plasmodium falciparum malaria will receive 30 mg KAE609 once a day for three days

Drug: KAE609

Interventions

KAE609 DRUG

KAE609 was supplied as capsules for oral use.

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female patients aged 20 to 60 years
• Presence of mono-infection of P. falciparum or P. vivax
• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (3)

Novartis Investigative Site

Bangkok, 10400, Thailand

Location

Novartis Investigative Site

Tak, 63110, Thailand

Location

Novartis Investigative Site

Tak Province, 63110, Thailand

Location

Related Publications (1)

• White NJ, Pukrittayakamee S, Phyo AP, Rueangweerayut R, Nosten F, Jittamala P, Jeeyapant A, Jain JP, Lefevre G, Li R, Magnusson B, Diagana TT, Leong FJ. Spiroindolone KAE609 for falciparum and vivax malaria. N Engl J Med. 2014 Jul 31;371(5):403-10. doi: 10.1056/NEJMoa1315860.

  PMID: 25075833 DERIVED

MeSH Terms

Conditions

Malaria; Acute malaria

Interventions

NITD 609

Condition Hierarchy (Ancestors)

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

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: January 30, 2012
• First Posted: February 1, 2012
• Study Start: January 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: May 13, 2013

Record last verified: 2013-05

Locations

TH (3)