A Pharmacokinetic (PK) Trial in Healthy Asian and Caucasian Volunteers Investigating the PK Profile of Eurartesim™

NCT01222949 | Completed Phase 1

• 1 other identifier: ST3073/ST3074-DM09-007
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

The Study was designed to evaluate the pharmacokinetics of DHA and PQ in healthy volunteers and to assess the effect of ethnicity (Asian vs Caucasian), gender and body weight on the relative bioavailability of DHA and PQ.

Conditions

Malaria, Falciparum

Outcome Measures

Primary Outcomes (1)

• PK: tmax, Cmax, AUC0-12(DHA), AUC0-24(PQ), AUC0-inf, λz, t1/2

  DHA evaluation: At pre-dose on day Day 0 and Day 2 and then at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dose. PQ evaluation: At pre-dose Day 0 and then at 1, 2, 3, 4, 5, 6, 8, 12, and 16 hours post-dose; then at pre-dose Day 1 and Day 2 and finally at 1, 2, 3, 4, 5, 6, 8, 12, and 16 hours post-dose on day 2; on Day 3, 4, 5, 7, 14, 21, 28, 42, 56 and 90.

  During the first and last day of drug administration (day 0 and 2) and followed up till Day 90

Secondary Outcomes (3)

• Number of Treatment Emergent Adverse Events (TEAEs)

  From Day 0 till Day 90

• Hematology and blood chemistry changes respect to baseline values

  Day 0, Day 3, Day 28, Day 90

• QTc interval prolongation

  Day 0, day 3, day 28, day 90

Study Arms (2)

Asian Healthy Volunteers

EXPERIMENTAL

Asian males with a body weight ≤ 65 kg (12 subjects) Asian females with a body weight ≤ 65 kg (12 subjects)

Drug: Eurartesim

Caucasian Healthy Volunteers

EXPERIMENTAL

Caucasian males with a body weight ≤ 65 kg (12 subjects) Caucasian females with a body weight ≤ 65 kg (12 subjects) Caucasian males with a body weight \> 65 kg (24 subjects)

Drug: Eurartesim

Interventions

Eurartesim DRUG

Tablet containing 40 mg of Dihydroartemisinin (DHA) and 320 mg of Piperaquine phosphate (PQP). 3 Tablets a Day for body weight comprised between 36 and 75 kg, 4 tablets for body weight above 75 kg.

Asian Healthy Volunteers; Caucasian Healthy Volunteers

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Caucasian or Asian healthy subjects, Male or female, aged between 18 and 50 years (inclusive)
• Body Mass Index (BMI) between 19.0 kg/m2 and 27.0 kg/m2 inclusive, with a minimum body weight of 36 kg.
• Agreed to use two approved methods of contraception
• Had given written informed consent to participate in this study in accordance with local regulations

You may not qualify if:

• Had received or was anticipated to receive a prescription medication within 14 days prior to the start of dosing
• Pregnant or lactating (females only)
• Abnormal laboratory test results deemed clinically significant at screening
• Positive urine drug test or alcohol breath test
• Acute therapy for a serious infection within 30 days of study entry
• History of significant drug allergies or significant allergic reactions
• Had participated in a clinical trial or had received an experimental therapy within 30 days or 10 half-lives of the drug
• Receipt of blood or blood products, or loss or donation of 450 mL or more of blood within 90 days before the first dose administration

Sponsors & Collaborators

• sigma-tau i.f.r. S.p.A.: lead
• CPR Pharma Services Pty Ltd, Australia: collaborator

Study Sites (2)

CMAX, a division of IDT Australia Limited

Adelaide, SA 5000, Australia

Location

Nucleus Network Limited

Melbourne, VIC 3004, Australia

Location

MeSH Terms

Conditions

Malaria, Falciparum

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 11, 2010
• First Posted: October 18, 2010
• Study Start: February 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: August 1, 2010
• Last Updated: October 18, 2010

Record last verified: 2010-10

Locations

AU (2)