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Study to Assess the Food Effect on the Pharmacokinetics of Nifurtimox Tablets in Chronic Chagas' Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02606864
Recruitment Status : Completed
First Posted : November 17, 2015
Last Update Posted : November 15, 2016
Information provided by (Responsible Party):

Brief Summary:
This study will evaluate the effect of food on the absorption of the drug as well as safety and tolerability of the novel 30 mg tablet (administered as 120 mg dose) in adults suffering from chronic Chagas' disease when administered after a high-fat / high-calorie test meal (American breakfast) compared to a fasting state. This study is required as part of the clinical development of an age appropriate pediatric oral dosage form for the treatment of Chagas' disease in endemic countries according to the recommendations provided by current international guidelines (EMA Guideline on Clinical Development of Medicinal Products, EMA Note for Guidance on Oral Dosage Forms).

Condition or disease Intervention/treatment Phase
Chagas Disease Drug: Nifurtimox (BAYa2502) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Non-blinded, Randomized, Single Center, Single Dose, Cross-over Study to Assess the Effect of a High Calorie/High Fat Meal on the Pharmacokinetics of Four 30 mg Nifurtimox Tablets Taken Orally by Adult Male and Female Patients Suffering From Chronic Chagas' Disease
Study Start Date : December 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chagas Disease

Arm Intervention/treatment
Experimental: BAYa2502 without food
Oral intake of a single 120 mg nifurtimox dose under fasted conditions
Drug: Nifurtimox (BAYa2502)
Oral Intake of 4 x 30 mg nifurtimox tablets

Experimental: BAYa2502 with food
Oral intake of a single 120 mg nifurtimox dose under fed conditions after ingestion of a high calorie and high fat breakfast
Drug: Nifurtimox (BAYa2502)
Oral Intake of 4 x 30 mg nifurtimox tablets

Primary Outcome Measures :
  1. Area under the drug-concentration vs. time curve of nifurtimox from time 0 to the last data point[AUC(0-tlast)] [ Time Frame: 0, 15, 30, 45 min, 1, 1.5, 2, 2.5, 4, 6, 8, 10, 12, 16, 24 hours ]
  2. Plasma concentration nifurtimox characterized by Cmax [ Time Frame: 0, 15, 30, 45 min, 1, 1.5, 2, 2.5, 4, 6, 8, 10, 12, 16, 24 hours ]
  3. Plasma concentration of nifurtimox characterized by tmax [ Time Frame: 0, 15, 30, 45 min, 1, 1.5, 2, 2.5, 4, 6, 8, 10, 12, 16, 24 hours ]
  4. Plasma concentration of nifurtimox characterized by AUC [ Time Frame: 0, 15, 30, 45 min, 1, 1.5, 2, 2.5, 4, 6, 8, 10, 12, 16, 24 hours ]

Secondary Outcome Measures :
  1. Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Study participants of reproductive potential must agree to utilize two reliable and acceptable methods of contraception simultaneously when sexually active. One of these methods must include a barrier method.

Subjects who are not of reproductive potential include: vasectomized males or non-vasectomized males with documented azospermia prior to screening, as well as females who are surgically sterilized with bilateral tubal ligation or who have undergone hysterectomy. Women who are menopausal are also considered not of reproductive potential if there has been no menses > 12 months prior to screening and supported by a pre-screening follicle stimulating hormone (FSH) > 40 mIU/ml if available.

Examples of reliable and acceptable methods of birth control include, but are not limited to: diaphragm with spermicide, condoms with spermicide or oral contraception with condom use in the male partner. This applies from the signing of the informed consent up until 12 weeks after the last dose of the study medication.

  • Male/female subject diagnosed with chronic Chagas' disease: Previous diagnosis of acute or chronic Chagas' disease by a health clinic prior to screening for the study. The diagnosis of chronic Chagas' disease may be made by clinical findings, supported by antibody titers if available. If there is a known history of acute disease, it is preferable to have documentation of parasites on the blood smear if available
  • Age: 18 to 45 years (inclusive) at the first screening visit
  • Body mass index (BMI): above/equal 18 and below/equal 29.9 kg / m²

Exclusion Criteria:

  • Incompletely cured pre-existing diseases (except chronic Chagas) for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
  • Acute Chagas'disease (During the acute phase, the parasite on a blood smear may be seen under a microscope. Different antibodies are present, depending on the course of the disease)
  • Known hypersensitivity to the study drugs (active substances or excipients of the preparations)
  • Unstable or uncontrolled medical condition such as hypertension or diabetes, decompensated heart failure, gastrointestinal (GI) conditions that would interfere with the absorption of the study drug (e.g. GI ulceration, peptic ulceration, GI bleeding, gastroesophageal reflux, or other GI disease affecting gastroesophageal junction), conditions that could potentially have an impact on drug metabolism or elimination (renal, hepatic such as known hepatic or biliary abnormalities), or any clinically relevant active infections in the opinion of the investigator within 4 weeks before the screening visit, e.g. clinically relevant history or presence of significant respiratory (e.g. interstitial lung disease), hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, metabolic (e.g. diabetes), and dermatological or connective tissue disease
  • Use of systemic or topical medicines or substances which oppose the study objectives or which might influence them within 4 weeks before the first study drug administration, e.g. an investigational drug, any drug altering GI motility and/or gastric pH (e.g. antacids, anticholinergic, para-sympatholytics), any drug known to induce liver enzymes (e.g. dexamethasone, barbiturates, St. John's Wort [hypericum perforatum]), any drug known to inhibit liver enzymes (e.g. ketoconazole, macrolides)
  • Clinically relevant findings in the ECG such as a second- or third-degree atrioventricular block, prolongation of the QRS complex over 120 msec or of the QT-interval over 450 msec using Bazett's Formula (QTcB) or Fridericia's Formula (QTcF). (clinically stable subjects with Chagas'- related heart disease and pacemaker in place for >1 year and evaluated by a cardiologist ≤6 months before the first dose of study drug will not be excluded.)
  • Systolic blood pressure below 100 or above 140 mmHg (after resting in supine position for a minimum of 3 min)
  • Diastolic blood pressure below 50 or above 90 mmHg (after resting in supine position for a minimum of 3 min)
  • Pulse rate below 45 or above 95 beats / min (after resting in supine position for a minimum of 3 min)
  • Findings that would exclude the subject in the physician's judgment e.g. enlarged liver, irregular heartbeat, undiagnosed acute illness, melanoma

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 identifier (NCT number): NCT02606864

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Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1425BAB
Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer
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Responsible Party: Bayer Identifier: NCT02606864    
Other Study ID Numbers: 16005
First Posted: November 17, 2015    Key Record Dates
Last Update Posted: November 15, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Chagas Disease
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents