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ObesePhase 1PQ in ObeseNCT02789566

Pharmacokinetic Study of Primaquine in Healthy Obese Thai Adult Subjects

A Phase 1 study testing Primaquine in people with Obese, run by University of Oxford at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of this study is to provide a description of the pharmacokinetic properties of primaquine and metabolites and characterize these in healthy obese Thai subjects. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Obese
What is being tested?
Primaquine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteThailand
Study dates
Aug 2011to Dec 2012
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.
  • Males and Females aged between 18 years to 60 years.
  • BMI ≥ 30 kg/m2 (BMI= body weight[BW](kg)/height(m2))
  • A female is eligible to enter and participate in this study if she is:
  • childbearing potential, has a negative serum pregnancy test at screening and urine pregnancy test prior to start the study drug in each period, and abstain from sexual intercourse or agrees to using 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
  • 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
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  • of non-childbearing potential including pre-menopausal females with documented (medical report verification) hysterectomy or double oophorectomy
  • A male is eligible to enter and participate in this study if he: agrees to abstain from (or use a condom during) 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.
  • Read, comprehend, and write at a sufficient level to complete study-related materials.
  • Provide a signed and dated written informed consent prior to study participation.
  • 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 points (heart failure, hypokalemia).
  • Subjects with a family history of sudden cardiac death.
  • A creatinine clearance <70 mL/min as determined by Salazar- Corcoran equations For men : [ 137- age]x [ ( 0.285x weight(kg0) +( 12.1x height(m)2]/ (51xSCr). For women; [146 - age]x( 0.287xweight(kg))+( 9.74xheight(m)2]/(60xSCr)
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  • Where age is in years, weight (wt) is in kg, and serum creatinine (Scr) is in units of mg/dL [Salazar, 1988].
  • History of alcohol or substance abuse or dependence within 6 months of the study: History of regular alcohol consumption averaging >7 drinks/wk for women or >14 drinks/wk for men. One drink is equivalent to 12 g alcohol = 5 oz (150 mL) of wine or 12 oz (360 mL) of beer or 1.5 oz (45 mL) of 80 proof distilled spirits within 6 months of screening.
  • 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 half-lives (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 half lives, 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.
  • 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. Subjects with unstable medical conditions that, in the opinion of the investigator would compromise their participation in the trial.
  • Subjects with unstable medical conditions that, in the opinion of the investigator would compromise their participation in the trial.
  • Those who, in the opinion of the investigator, have a risk of non-compliance with study procedures.
  • Lack of suitability for participation in this study, for any reason, in the opinion of the investigator.
  • AST or ALT >1.5 upper limit of normal (ULN)
  • Subjects with history of renal disease, hepatic disease, and/or cholecystectomy
  • G6PD deficient.
  • Abnormal methaemoglobin level. (Normal range 0-3%)
  • History of malaria treatment with Primaquine within 12 months

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Faculty of Tropical Medicine, Mahidol University

    Bangkok, Bangkok, 10400

Other trials in Thailand

About this study

Official title: Phase 1, Open-Label Study to Evaluate Potential Pharmacokinetic of Orally Administered Primaquine in Healthy Obese Thai Adult Subjects

The primary objective of this study is to provide a description of the pharmacokinetic properties of primaquine and metabolites and characterize these in healthy obese Thai subjects.

This is an open-label, single dose pharmacokinetic study in 10 healthy obese G6PD normal, subjects will be admitted as inpatient to receive 1 regimen for 1 visit only.

Read the detailed description

Subjects will have 1 hospitalization. The visit will require hospitalization for about 24 hours. After the screening (visit 1), the subject will receive Primaquine (PQ) 30 mg base single dose at first admission (visit 2). Assessment of the safety profile will be done after admission by the investigating team before proceeding to the regimen.

The study will enroll 10 healthy obese subjects (Body mass index [BMI] ≥30 kg/m2) both male and female, age 18-60 years, from the pharmacokinetic unit at Faculty of Tropical Medicine, Mahidol University. Participants will be healthy HIV-1, hepatitis B and C uninfected individuals who comprehend the purpose of the study and have provided written consent. Participants will be screened and eligibility will be based on inclusion and exclusion criteria. If all doses are completed without replacement of subjects, the total number of subjects in this study is 10. All subjects will undergo screening assessments within 7 days prior to the single dose to determine their eligibility for enrollment into the study.

Conditions
Obese
Being tested
Primaquine
Keywords
Primaquine, Pharmacokinetic
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PrimaquineDrug

    Primaquine 30 mg taken after meal in the morning.

Study groups in NCT02789566
Study groupRoleWhat they receive
RegimenExperimentalPrimaquine (PQ) 30 mg base single dose
Receives: Drug: Primaquine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area under the plasma concentration time AUC 0-∞curve for primaquine and metabolites (mPQ)

    Measured: 24 hours

Secondary outcomes (4)

  1. Metabolites (mPQ) maximum concentrations (Cmax) of Primaquine

    Measured: 24 hours

  2. Metabolites (mPQ) elimination rate constants (mPQ-λz)

    Measured: 24 hours

  3. Elimination half life (mPQ-t1/2) of Primaquine

    Measured: 24 hours

  4. Number of adverse events (Safety and tolerability)

    adverse events, clinical laboratory and vital signs assessments will be assessed

    Measured: 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2016 (estimated)
  2. Study startAug 2011
  3. Primary completionNov 2011
  4. Study completionDec 2012

Resources

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
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02789566
Sponsor's protocol ID
TMEC 11-010
Acronym
PQ in Obese
Status last verified
May 2016
First submitted
23 May 2016
Last updated
3 Jun 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Primaquine in people with Obese, 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 12 inclusion and 21 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 3 Jun 2016. 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 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?

Area under the plasma concentration time AUC 0-∞curve for primaquine and metabolites (mPQ) (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02789566.

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 3 Jun 2016.

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