Food Interaction Study on the Pharmacokinetics of Eurartesim™ (DHA and PQP)in Healthy Male Adult Volunteers

Phase 1

Completed

• Conditions: Malaria, Falciparum
• Interventions: Drug: Eurartesim

• Registration Number: NCT01222962
• Lead Sponsor: sigma-tau i.f.r. S.p.A.

Brief Summary

The study was designed to assess the effect of food on the extent and rate of absorption of Dihydroartemisinin (DHA) and Piperaquine Phosphate (PQP) administered as a fixed dose combination (Eurartesim™).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2010-05
• Study Completion: 2010-06
• Status Verified: 2010-10
• Study First Submitted: 2010-10-11
• Study First Submitted QC: 2010-10-14
• Last Update Submitted: 2010-10-14
• Study First Posted: 2010-10-18
• Last Update Posted: 2010-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 37

Inclusion Criteria

• Caucasian healthy males 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 75 kg.
• Agreed to use two approved methods of contraception from Screening and until 90 days after administration of the study drug
• 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 or an over-the-counter medicine 48 hours prior to the start of dosing.
• Abnormal laboratory test results deemed clinically significant by the Medical Officer.
• Positive urine drug test (e.g. opiates and cannabinoids) or alcohol breath test.
• History of significant drug allergies or significant allergic reaction.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fed treatment	Eurartesim	18 healthy volunteers administered with a single dose of Eurartesim
Fasted Treatment	Eurartesim	18 healthy volunteers treated with a single dose of Eurartesim

Primary Outcome Measures

Name	Time	Method
tmax, Cmax, AUC0-last, AUC0-24 [PQ], and AUC0-inf, λz, t1/2, Cl/F, Vz/F [DHA].	from the day of study drug administration, till Day 7 follow-up	Blood samples for determination of plasma DHA were collected at the following times: At pre-dose Day 0 and then at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dose.; Blood samples for determination of plasma PQ were collected at the following times: At pre-dose Day 0 and then at 1, 2, 3, 4, 5, 6, 8, and 12 hours post-dose; on Day 1, 2, 3, 4, 5 and 7.

Secondary Outcome Measures

Name	Time	Method
Number of Treatment Emergent Adverse Events	Day 0 and till Day 30 follow-up	Number of TEAEs and number of Subjects experiencing Adverse Events during all the study period
Hematology and blood chemistry changes respect to baseline values	Day 0, day 2, day 30	Abnormalities in hematology (Haemoglobin, Hematocrit,RBC count, White cell count and differential count, Platelets) and clinical chemistry (Protein, Sodium, Potassium, Chloride ,Total Bilirubin, Conjugated Bilirubin, Alanine Aminotransferase, Aspartate Aminotransferase, Total Cholesterol, Glucose, Bicarbonate, Urea, Urate, Lactate Dehydrogenase, Albumin, Globulins, Triglycerides, Creatinine, Alkaline Phosphatase, Gamma glutamyltransferase, Total Calcium, Phosphate, C-reactive protein) will be recorded the day of the last study drug intake and after 30 days from the start of the drug treatment
QTc interval prolongation	Day 0, day 2, day 30	ECG recordings will be obtained at baseline, after the last drug intake and 30 days follow-up to investigate changes in ECG parameters, and specifically QTc interval changes respect to baseline

Trial Locations

Locations (1)

CMAX, a division of IDT Australia Limited; 🇦🇺 Adelaide, Australia