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

Sigma-Tau Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Malaria, Falciparum

Treatments: Drug: Eurartesim

Study type: Interventional

Funder types: Industry

Identifiers

NCT01222949

ST3073/ST3074-DM09-007

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Asian Healthy Volunteers

Experimental group

Description:

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

Treatment:

Drug: Eurartesim

Caucasian Healthy Volunteers

Experimental group

Description:

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)

Treatment:

Drug: Eurartesim