Malaria, FalciparumPhase 1NCT01222949
A Pharmacokinetic (PK) Trial in Healthy Asian and Caucasian Volunteers Investigating the PK Profile of Eurartesim™
A Phase 1 study testing Eurartesim in people with Malaria, Falciparum, run by sigma-tau i.f.r. S.p.A. at 2 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria, Falciparum
- What is being tested?
- Eurartesim
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesAustralia
- Study dates
- Feb 2010to Aug 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Australia2 sites
CMAX, a division of IDT Australia Limited
Adelaide, SA 5000
Nucleus Network Limited
Melbourne, VIC 3004
About this study
Official title: A Phase I, Pharmacokinetic Trial, in Healthy Asian and Caucasian Volunteers for Investigating the Pharmacokinetic Profiles of Eurartesim™ (40 mg Dihydroartemisinin (DHA)/320 mg Piperaquine (PQ) Phosphate.
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
- Being tested
- Eurartesim
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EurartesimDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Asian Healthy Volunteers | Experimental | Asian males with a body weight ≤ 65 kg (12 subjects) Asian females with a body weight ≤ 65 kg (12 subjects) Receives: 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) Receives: Drug: Eurartesim |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Number of TEAEs and number of Subjects experiencing Adverse Events during all the study period
Measured: From Day 0 till Day 90
Hematology and blood chemistry changes respect to baseline values
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
Measured: Day 0, Day 3, Day 28, Day 90
QTc interval prolongation
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
Measured: Day 0, day 3, day 28, day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2010 (estimated)
- Study startFeb 2010
- Primary completionJul 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malaria, FalciparumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- sigma-tau i.f.r. S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CPR Pharma Services Pty Ltd, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01222949
- Sponsor's protocol ID
- ST3073/ST3074-DM09-007
- Status last verified
- Oct 2010
- First submitted
- 11 Oct 2010
- Last updated
- 18 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Pharmacokinetic Trial, in Healthy Asian and Caucasian Volunteers for Investigating the Pharmacokinetic Profiles of Eurartesim™ (40 mg Dihydroartemisinin (DHA)/320 mg Piperaquine (PQ) Phosphate.
- ClinicalTrials.gov ID
- NCT01222949
- Acronym / sponsor ID
- ST3073/ST3074-DM09-007
- Conditions
- Malaria, Falciparum
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- sigma-tau i.f.r. S.p.A.Industry (pharma, biotech, devices)
- Collaborators
- CPR Pharma Services Pty Ltd, Australia
- Study start
- Feb 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 18 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asian Healthy Volunteers | Experimental | Drug: EurartesimAsian males with a body weight ≤ 65 kg (12 subjects) Asian females with a body weight ≤ 65 kg (12 subjects) |
| Caucasian Healthy Volunteers | Experimental | Drug: EurartesimCaucasian 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) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EurartesimTablet 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. | Drug | Asian Healthy Volunteers, Caucasian Healthy Volunteers |
Primary outcome
PK: tmax, Cmax, AUC0-12(DHA), AUC0-24(PQ), AUC0-inf, λz, t1/2
Time frame: During the first and last day of drug administration (day 0 and 2) and followed up till Day 90
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.
3 secondary outcomes
Number of Treatment Emergent Adverse Events (TEAEs)
Time frame: From Day 0 till Day 90
Hematology and blood chemistry changes respect to baseline values
Time frame: Day 0, Day 3, Day 28, Day 90
QTc interval prolongation
Time frame: Day 0, day 3, day 28, day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Eurartesim in people with Malaria, Falciparum, run by sigma-tau i.f.r. S.p.A. at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PK: tmax, Cmax, AUC0-12(DHA), AUC0-24(PQ), AUC0-inf, λz, t1/2 (time frame: During the first and last day of drug administration (day 0 and 2) and followed up till Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2010.