PharmacokineticPhase 1ALAQNCT04080895
Pharmacokinetic Study of Artemether-lumefantrine and Amodiaquine in Healthy Subjects
A Phase 1 study testing Artemether-lumefantrine, Amodiaquine and Artemether-lumefantrine + Amodiaquine in people with Pharmacokinetic and Healthy, run by University of Oxford at 1 site in Thailand.
Trial summary
This is an open-label pharmacokinetic study in 16 healthy Thai subjects. To assess the safety and tolerability and pharmacological interactions of the combination of artemether-lumefantrine and amodiaquine. This study is funded by Prof White's WT PRF. The Welcome Trust grant reference number is B9R04920. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetic, Healthy, Drug Combination
- What is being tested?
- Artemether-lumefantrine, Amodiaquine and Artemether-lumefantrine + Amodiaquine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteThailand
- Study dates
- 1 Nov 2022to 1 Apr 2025
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy as judged by a responsible physician with no abnormality identified on a medical evaluation including medical history and physical examination.
- Male or female non-smoker aged between 18 years to 60 years.
- A female is eligible to enter and participate in this study if she is:
- of non-childbearing potential including pre-menopausal females with documented (medical report verification) hysterectomy or double oophorectomy
- or postmenopausal defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum follicle stimulating hormone levels >40 mIU/mL or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy
- or of childbearing potential, has a negative serum pregnancy test at screening and prior to start the study drug in each period, and agrees to abstain from sexual intercourse or use effective contraceptive methods (e.g., intrauterine device, hormonal contraceptive drug, tubal ligation or female barrier method with spermicide) during the study until completion of the follow-up procedures
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- A male is eligible to enter and participate in this study if he: agrees to abstain from sexual intercourse with females of childbearing potential or lactating females; or is willing to use a condom/spermicide, during the study until completion of the follow-up procedures.
- Normal electrocardiogram (ECG) with QTc <450 msec.
- Willingness and ability to comply with the study protocol for the duration of the trial.
Who cannot join
- Females who are pregnant, trying to get pregnant, or are lactating.
- The subject has evidence of active substance abuse that may compromise safety, pharmacokinetics, or ability to adhere with protocol instructions.
- A positive pre-study hepatitis B surface antigen, positive hepatitis C antibody, or positive human immunodeficiency virus-1 (HIV-1) antibody result at screening.
- Subjects with a personal history of cardiac disease, symptomatic or asymptomatic arrhythmias, syncopal episodes, or additional risk factors for torsades de pointes (heart failure, hypokalemia) or with a family history of long QT syndrome, Brugada syndrome, or sudden cardiac death.
- Abnormal serum creatinine (Scr) and estimated glomerular filtration rate (eGFR) <70 mL/min as determined by CKD-EPI equation
- History of alcohol or substance abuse or dependence within 6 months of the study.
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- Use of prescription or non-prescription drugs except paracetamol at doses of up to 2 grams/day, including vitamins, herbal and dietary supplements (including St. John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 times the drug half-life (whichever is longer) prior to the first dose of study medication until the completion of the follow-up procedure, unless in the opinion of investigator, the medication will not interfere with the study procedures or compromise subject safety; the investigator will take advice from the manufacturer representative as necessary.
- The subject has participated in a clinical trial and has received a drug or a new chemical entity within 30 days or 5 x half-life, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of study medication.
- The subject is unwilling to abstain from ingesting alcohol within 48 hours prior to the first dose of study medication until collection of the final pharmacokinetic sample during each regimen.
- Subjects who have donated blood to the extent that participation in the study would result in more than 300 mL blood donated within a 30-day period. Note: This does not include plasma donation.
- Subjects who have a history of allergy to the study drug or drugs of this class, or a history of drug or other allergy that, in the opinion of the investigator, contraindicates participation in the trial. In addition, if heparin is used during pharmacokinetic sampling, subjects with a history of sensitivity to heparin or heparin-induced thrombocytopenia should not be enrolled.
- Lack of suitability for participation in this study, including but not limited to, unstable medical conditions, systemic disease manifested by tendency to granulocytopenia e.g. rheumatoid arthritis and lupus erythematosus that in the opinion of the investigator would compromise their participation in the trial.
- AST or ALT >1.5 times the upper limit of normal (ULN)
- Subjects with history of renal disease, hepatic disease, and/or cholecystectomy
- Abnormal methemoglobin level (more than 3 mg/dL).
- History of antimalarial drugs use including but not limited to mefloquine, chloroquine, primaquine, artesunate, piperaquine and pyronaridine treatment within 6 months.
- Subject who have received quinacrine in last 30 days.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Tropical Medicine, Mahidol University
Bangkok, 10400
About this study
Official title: A Randomized, Open-Label Study to Evaluate Potential Pharmacokinetic Interactions of Orally Administered Artemether-lumefantrine and Amodiaquine in Healthy Adult Subjects
This is an open-label pharmacokinetic study in 16 healthy Thai subjects. To assess the safety and tolerability and pharmacological interactions of the combination of artemether-lumefantrine and amodiaquine.
This study is funded by Prof White's WT PRF. The Welcome Trust grant reference number is B9R04920.
Read the detailed description
This study will enroll 16 healthy subjects both male and female, aged 18-60 years, at the Clinical Therapeutic Unit, Faculty of Tropical Medicine, Mahidol University. Subjects will be healthy HIV-1, hepatitis B and C uninfected individuals who comprehend the purpose of the study and have provided written consent. All subjects will undergo screening assessments (visit 1). Screening assessments (visit 1) may be carried out over more than one day, provided that all required assessments are completed within the 14 days prior to visit 2. If the interval between screening (visit 1) and day -1 visit 2 is three days or less, the clinical laboratory screening test result and serum pregnancy test result can be used for enrolment evaluation on day -1 visit 2. In such cases, these tests would not need to be repeated at day-1 visit 2.
Visit 1 (Screening visit): All laboratory assessments (chemistry, hematology, FBS and urinalysis) must be drawn in the fasting state (8 hours fast) including serum pregnancy testing (if appropriate)
Visit 2-4: 16 healthy subjects who fulfill the eligibility criteria will be recruited and randomized to the study. All laboratory assessments (chemistry, hematology, FBS and urinalysis) must be drawn in the fasting state (8 hours fast). Results of these tests are to be available and reviewed prior to each subject receiving the study drug on day 0.
- Conditions
- Pharmacokinetic, Healthy, Drug Combination
- Being tested
- Artemether-lumefantrine, Amodiaquine, Artemether-lumefantrine + Amodiaquine
- Keywords
- Artemether-lumefantrine, Amodiaquine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artemether-lumefantrineDrug
Artemether-lumefantrine on Day 0, 1 and 2 Washout period: more than 6 weeks
AmodiaquineDrug
Amodiaquine on Day 0, 1 and 2 Washout period: more than 6 weeks
Artemether-lumefantrineDrug
Artemether-lumefantrine on Day 0, 1 and 2 Washout period: more than 6 weeks
Artemether-lumefantrine + AmodiaquineDrug
Artemether-lumefantrine + Amodiaquine on Day 0, 1 and 2
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | Not described Receives: Drug: Artemether-lumefantrine; Drug: Amodiaquine; Drug: Artemether-lumefantrine + Amodiaquine |
| group B | Experimental | Not described Receives: Drug: Amodiaquine; Drug: Artemether-lumefantrine; Drug: Artemether-lumefantrine + Amodiaquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve (AUC0-∞)
of artemether, lumefantrine and amodiaquine and their metabolites when given alone and in combination.
Measured: approximately 6 - 12 months
Area under the concentration-time curve AUC (0-last)
of artemether, lumefantrine and amodiaquine and their metabolites when given alone and in combination.
Measured: approximately 6 - 12 months
maximum concentration (Cmax)
of artemether, lumefantrine and amodiaquine and their metabolites when given alone and in combination.
Measured: approximately 6 - 12 months
Secondary outcomes (8)
Elimination clearance (CL/F)
of artemether, lumefantrine and amodiaquine and their metabolites when given alone and in combination.
Measured: approximately 6 - 12 months
terminal elimination half-life (t1/2)
of artemether, lumefantrine and amodiaquine and their metabolites when given alone and in combination.
Measured: approximately 6 - 12 months
apparent volume of distribution (Vd)
of artemether, lumefantrine and amodiaquine and their metabolites when given alone and in combination.
Measured: approximately 6 - 12 months
Number of adverse events
Adverse events will be assessed as one of safety and tolerability parameters.
Measured: approximately 6 - 12 months
Number of event concerning of abnormal electrocardiograph
Electrocardiographic changes especially QTc interval prolongation will be assessed as one of safety and tolerability parameters.
Measured: approximately 6 - 12 months
Number of event concerning of abnormal vital signs
Abnormal vital signs will be assessed as one of safety and tolerability parameters.
Measured: approximately 6 - 12 months
Number of event concerning of abnormal laboratory values
Abnormal laboratory values will be assessed as one of safety and tolerability parameters.
Measured: approximately 6 - 12 months
Pharmacogenetic polymorphisms identification
Genotyping will be performed to identify polymorphisms of cytochrome 450 and other enzymes related to drug metabolism from subject who is an unusual metabolizer.
Measured: approximately 6 - 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start1 Nov 2022
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Why it stopped: The decision was made due to the expired investigational drug and regulatory changes by the Thai FDA, along with increased importation costs. The research team and investigational drug sponsor agreed to seek approval for early project termination.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Crossover
- Model description
- This is an open-label pharmacokinetic study in 16 healthy Thai subjects. Subjects will be admitted in the inpatient ward and will be randomized to group A or group B to receive 3 drug regimens (Regimen 1 Artemether-lumefantrine; Regimen 2 Amodiaquine ; Regimen 3 Artemether-lumefantrine + Amodiaquine) on Day 0, 1, and 2. Every subject will have 1 screening and 3 admissions in the hospital.
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Mahidol University, Mahidol Oxford Tropical Medicine Research Unit
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04080895
- Sponsor's protocol ID
- MAL19003
- Acronym
- ALAQ
- Status last verified
- Apr 2025
- First submitted
- 10 Jun 2019
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: With subject's consent, subject's clinical data and results from blood analyses stored in our database may be shared with other researchers to use in the future.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label Study to Evaluate Potential Pharmacokinetic Interactions of Orally Administered Artemether-lumefantrine and Amodiaquine in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT04080895
- Acronym / sponsor ID
- ALAQ / MAL19003
- Conditions
- Pharmacokinetic, Healthy, Drug Combination
- Keywords
- Artemether-lumefantrine, Amodiaquine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The decision was made due to the expired investigational drug and regulatory changes by the Thai FDA, along with increased importation costs. The research team and investigational drug sponsor agreed to seek approval for early project termination.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Mahidol University, Mahidol Oxford Tropical Medicine Research Unit
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 6 Sep 2019 (actual)
- 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.
This is an open-label pharmacokinetic study in 16 healthy Thai subjects. To assess the safety and tolerability and pharmacological interactions of the combination of artemether-lumefantrine and amodiaquine.
This study is funded by Prof White's WT PRF. The Welcome Trust grant reference number is B9R04920.
Detailed description
This study will enroll 16 healthy subjects both male and female, aged 18-60 years, at the Clinical Therapeutic Unit, Faculty of Tropical Medicine, Mahidol University. Subjects will be healthy HIV-1, hepatitis B and C uninfected individuals who comprehend the purpose of the study and have provided written consent. All subjects will undergo screening assessments (visit 1). Screening assessments (visit 1) may be carried out over more than one day, provided that all required assessments are completed within the 14 days prior to visit 2. If the interval between screening (visit 1) and day -1 visit 2 is three days or less, the clinical laboratory screening test result and serum pregnancy test result can be used for enrolment evaluation on day -1 visit 2. In such cases, these tests would not need to be repeated at day-1 visit 2.
Visit 1 (Screening visit): All laboratory assessments (chemistry, hematology, FBS and urinalysis) must be drawn in the fasting state (8 hours fast) including serum pregnancy testing (if appropriate)
Visit 2-4: 16 healthy subjects who fulfill the eligibility criteria will be recruited and randomized to the study. All laboratory assessments (chemistry, hematology, FBS and urinalysis) must be drawn in the fasting state (8 hours fast). Results of these tests are to be available and reviewed prior to each subject receiving the study drug on day 0.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an open-label pharmacokinetic study in 16 healthy Thai subjects. Subjects will be admitted in the inpatient ward and will be randomized to group A or group B to receive 3 drug regimens (Regimen 1 Artemether-lumefantrine; Regimen 2 Amodiaquine ; Regimen 3 Artemether-lumefantrine + Amodiaquine) on Day 0, 1, and 2. Every subject will have 1 screening and 3 admissions in the hospital.
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Drug: Artemether-lumefantrine, Drug: Amodiaquine, Drug: Artemether-lumefantrine + Amodiaquine |
| group B | Experimental | Drug: Amodiaquine, Drug: Artemether-lumefantrine, Drug: Artemether-lumefantrine + Amodiaquine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy as judged by a responsible physician with no abnormality identified on a medical evaluation including medical history and physical examination.
- Male or female non-smoker aged between 18 years to 60 years.
- A female is eligible to enter and participate in this study if she is:
- A male is eligible to enter and participate in this study if he: agrees to abstain from sexual intercourse with females of childbearing potential or lactating females; or is willing to use a condom/spermicide, during the study until completion of the follow-up procedures.
- Normal electrocardiogram (ECG) with QTc <450 msec.
Key exclusion criteria (17 listed)
- Females who are pregnant, trying to get pregnant, or are lactating.
- The subject has evidence of active substance abuse that may compromise safety, pharmacokinetics, or ability to adhere with protocol instructions.
- A positive pre-study hepatitis B surface antigen, positive hepatitis C antibody, or positive human immunodeficiency virus-1 (HIV-1) antibody result at screening.
- Subjects with a personal history of cardiac disease, symptomatic or asymptomatic arrhythmias, syncopal episodes, or additional risk factors for torsades de pointes (heart failure, hypokalemia) or with a family history of long QT syndrome, Brugada syndrome, or sudden cardiac death.
- Abnormal serum creatinine (Scr) and estimated glomerular filtration rate (eGFR) <70 mL/min as determined by CKD-EPI equation
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 |
|---|---|---|
| Artemether-lumefantrineArtemether-lumefantrine on Day 0, 1 and 2 Washout period: more than 6 weeks | Drug | group A |
| AmodiaquineAmodiaquine on Day 0, 1 and 2 Washout period: more than 6 weeks | Drug | group A, group B |
| Artemether-lumefantrineArtemether-lumefantrine on Day 0, 1 and 2 Washout period: more than 6 weeks | Drug | group B |
| Artemether-lumefantrine + AmodiaquineArtemether-lumefantrine + Amodiaquine on Day 0, 1 and 2 | Drug | group A, group B |
Primary outcome
Area under the concentration-time curve (AUC0-∞)
Time frame: approximately 6 - 12 months
of artemether, lumefantrine and amodiaquine and their metabolites when given alone and in combination.
Area under the concentration-time curve AUC (0-last)
Time frame: approximately 6 - 12 months
of artemether, lumefantrine and amodiaquine and their metabolites when given alone and in combination.
maximum concentration (Cmax)
Time frame: approximately 6 - 12 months
of artemether, lumefantrine and amodiaquine and their metabolites when given alone and in combination.
8 secondary outcomes
Elimination clearance (CL/F)
Time frame: approximately 6 - 12 months
terminal elimination half-life (t1/2)
Time frame: approximately 6 - 12 months
apparent volume of distribution (Vd)
Time frame: approximately 6 - 12 months
Number of adverse events
Time frame: approximately 6 - 12 months
Number of event concerning of abnormal electrocardiograph
Time frame: approximately 6 - 12 months
Number of event concerning of abnormal vital signs
Time frame: approximately 6 - 12 months
Number of event concerning of abnormal laboratory values
Time frame: approximately 6 - 12 months
Pharmacogenetic polymorphisms identification
Time frame: approximately 6 - 12 months
Results and safety
The study was stopped early (reason given: The decision was made due to the expired investigational drug and regulatory changes by the Thai FDA, along with increased importation costs. The research team and investigational drug sponsor agreed to seek approval for early project termination.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: Yes. With subject's consent, subject's clinical data and results from blood analyses stored in our database may be shared with other researchers to use in the future.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Artemether-lumefantrine, Amodiaquine and Artemether-lumefantrine + Amodiaquine in people with Pharmacokinetic and Healthy, run by University of Oxford at 1 site in Thailand.
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 9 inclusion and 17 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: stopped early, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. 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 was stopped early (reason given: The decision was made due to the expired investigational drug and regulatory changes by the Thai FDA, along with increased importation costs. The research team and investigational drug sponsor agreed to seek approval for early project termination.). Results are not available in the source record.
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?
Area under the concentration-time curve (AUC0-∞) (time frame: approximately 6 - 12 months). The study lists 3 primary outcomes in all. 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 12 Jan 2026.