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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAYa2502 without food | Experimental | Oral intake of a single 120 mg nifurtimox dose under fasted conditions |
|
| BAYa2502 with food | Experimental | Oral intake of a single 120 mg nifurtimox dose under fed conditions after ingestion of a high calorie and high fat breakfast |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nifurtimox (BAYa2502) | Drug | Oral Intake of 4 x 30 mg nifurtimox tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the drug-concentration vs. time curve of nifurtimox from time 0 to the last data point[AUC(0-tlast)] | 0, 15, 30, 45 min, 1, 1.5, 2, 2.5, 4, 6, 8, 10, 12, 16, 24 hours | |
| Plasma concentration nifurtimox characterized by Cmax | 0, 15, 30, 45 min, 1, 1.5, 2, 2.5, 4, 6, 8, 10, 12, 16, 24 hours | |
| Plasma concentration of nifurtimox characterized by tmax | 0, 15, 30, 45 min, 1, 1.5, 2, 2.5, 4, 6, 8, 10, 12, 16, 24 hours | |
| Plasma concentration of nifurtimox characterized by AUC | 0, 15, 30, 45 min, 1, 1.5, 2, 2.5, 4, 6, 8, 10, 12, 16, 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events as a measure of safety and tolerability | Up to 8 weeks |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Buenos Aires | Ciudad Auton. de Buenos Aires | C1425BAB | Argentina |
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| ID | Term |
|---|---|
| D014355 | Chagas Disease |
| ID | Term |
|---|---|
| D014352 | Trypanosomiasis |
| D056986 | Euglenozoa Infections |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
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| ID | Term |
|---|---|
| D009547 | Nifurtimox |
| ID | Term |
|---|---|
| D009581 | Nitrofurans |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
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| D007239 |
| Infections |
| D000079426 | Vector Borne Diseases |
| D013457 |
| Sulfur Compounds |
| D005663 | Furans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |