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Trial record 69 of 914 for:    tablet | Japan

Single Oral Dose Study of Atovaquone/Proguanil Hydrochloride Combination Tablets and Atovaquone Suspension

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ClinicalTrials.gov Identifier: NCT01858831
Recruitment Status : Completed
First Posted : May 21, 2013
Last Update Posted : March 22, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:

This study will be a single-center, phase I, randomized, open, in fed condition, parallel, single dose study to evaluate the pharmacokinetics and the safety, tolerability of Atovaquone/proguanil combination tablets and atovaquone suspension in Japanese healthy male subjects.

Serial blood samples will be collected for the determination of the plasma concentration of atovaquone, proguanil and cycloguanil after dosing of atovaquone 1000mg/proguanil 400 mg and the plasma atovaquone concentration of atovaquone 750 and 1500 mg. Safety assessments will be performed for each treatment group.

CYP2C19 contribute to proguanil metabolism. CYP2C19 genotype will be determined in atovaquone/proguanil dosing group.


Condition or disease Intervention/treatment Phase
Malaria Drug: Atovaquone/proguanil HCL Drug: Atovaquone Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Single Oral Dose Study of Atovaquone/Proguanil Hydrochloride Combination Tablets and Atovaquone Suspension. - A Single Oral Dose Study to Investigate Pharmacokinetics of Atovaquone and Proguanil From Combination Tablets and Atovaquone From Atovaquone Suspension in Japanese Healthy Males. -
Study Start Date : April 2012
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Atovaquone/proguanil HCL
Atovaquone/proguanil HCL
Drug: Atovaquone/proguanil HCL
Atovaquone/proguanil HCL

Active Comparator: Atovaquone 750 mg
Atovaquone 750 mg
Drug: Atovaquone
Atovaquone

Active Comparator: Atovaquone 1500 mg
Atovaquone 1500 mg
Drug: Atovaquone
Atovaquone




Primary Outcome Measures :
  1. plasma atovaquone concentration [ Time Frame: pre, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 120, 168, 216, 336 post dose ]
  2. plasma proguanil concentration [ Time Frame: pre, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 120, 168, 216, 336 post dose ]
  3. plasma cycloguanil concentration [ Time Frame: pre, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 120, 168, 216, 336 post dose ]

Secondary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: up to 336h post dose ]
  2. Change in Systolic Blood Pressure [ Time Frame: at pre-dose, 4, 24, 72, 168 and 336 h post-dose ]
    Change values at 4, 24, 72, 168 and 336 h post-dose from baseline (pre-dose)

  3. Change in ECG findings [ Time Frame: at pre-dose, 4, 72, 168 and 336 h post-dose ]
    Change at 4, 72, 168 and 336 h post-dose from baseline (pre-dose)

  4. Laboratory [ Time Frame: at pre-dose, 72, 168 and 336 h post-dose ]
    Change values at 72, 168 and 336 h post-dose from baseline (pre-dose)

  5. Change in Diastolic Blood Pressure [ Time Frame: at pre-dose, 4, 24, 72, 168 and 336 h post-dose ]
    Change values at 4, 24, 72, 168 and 336 h post-dose from baseline (pre-dose)

  6. Change in Heart rate [ Time Frame: at pre-dose, 4, 24, 72, 168 and 336 h post-dose ]
    Change values at 4, 24, 72, 168 and 336 h post-dose from baseline (pre-dose)

  7. Change in Hematology values [ Time Frame: at pre-dose, 72, 168 and 336 h post-dose ]
    Change values at 72, 168 and 336 h post-dose from baseline (pre-dose)

  8. Change in Biochemistry values [ Time Frame: at pre-dose, 72, 168 and 336 h post-dose ]
    Change values at 72, 168 and 336 h post-dose from baseline (pre-dose)

  9. Change in Urinalysis values [ Time Frame: at pre-dose, 72, 168 and 336 h post-dose ]
    Change values at 72, 168 and 336 h post-dose from baseline (pre-dose)



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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy as defined as being free from clinically significant illness or disease as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, vital sign, laboratory tests and ECG.
  • Japanese healthy male between 20 and 55 years of age inclusive, at the time of signing the informed consent.
  • Body weight => 50 kg and BMI within the range 18.5- 25 kg/m2
  • Non-smoker or ex-smoker having ceased smoking for at least 6 months. (inclusive).
  • ALT, alkaline phosphatase and bilirubin below the upper limit of normal (ULN)
  • Single QTcB< 450 msec.
  • Vital sign within the following ranges; Systolic blood pressure: < 90 mmHg or > 140 mmHg, Diastolic blood pressure: < 45 mmHg or > 90 mmHg, Plus rate: < 45 bpm or > 100 bpm, Body temperature: 37.5 C
  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Exclusion Criteria:

  • A positive results of syphilis, HBs antigen, HCV antibody, HIV antibody and HTLV-1 antibody at the time of screening.
  • History of any cardiac diseases irrespective of with or without symptom.
  • An episode of cardiac syncope within one year before screening period.
  • History/evidence of clinically significant pulmonary diseases and hyper/hypo-thyroidism.
  • Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • A positive pre-study drug screen.
  • History of regular alcohol consumption exceeding, on average, 14 drinks/week for men (1 drink = 5 ounces (150 mL) of wine or 350 mL of beer or 1.5 ounces (45 mL) of 80 proof distilled spirits) within 6 months of screening.
  • The subject had participated in a clinical study or post-marketing study with an investigational or a non-investigational product during the previous 4 months preceding the administration of study medication of this study.
  • The subject had participated in a clinical study or post-marketing study with an investigational or a non-investigational product during the previous 4 months preceding the administration of study medication of this study.
  • Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
  • Unable to refrain from the use of alcohol, prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.
  • History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy excluding pollen allergy without current symptoms.
  • Where participation in the study would result in donation of blood or blood products in excess of 400 mL within a 4 month or 200 mL within 2 month.
  • Unwillingness or inability to follow the procedures outlined in the protocol.
  • Subject is mentally or legally incapacitated.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01858831


Locations
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Japan
GSK Investigational Site
Kagoshima, Japan, 890-0081
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01858831     History of Changes
Other Study ID Numbers: 116441
First Posted: May 21, 2013    Key Record Dates
Last Update Posted: March 22, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
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Atovaquone
Proguanil
Atovaquone, proguanil drug combination
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites