Status:
COMPLETED
Single Oral Dose Study of Atovaquone/Proguanil Hydrochloride Combination Tablets and Atovaquone Suspension
Lead Sponsor:
GlaxoSmithKline
Conditions:
Malaria
Eligibility:
MALE
20-55 years
Phase:
PHASE1
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 combi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01858831
Start Date
April 1 2012
End Date
May 1 2012
Last Update
March 22 2017
Active Locations (1)
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1
GSK Investigational Site
Kagoshima, Japan, 890-0081