Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 20 for:    2502 AND dose

Study to Assess Bioequivalence of a New Nifurtimox Oral Tablet Formulation

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03708133
Recruitment Status : Recruiting
First Posted : October 17, 2018
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:

The primary objective of the current study is to investigate the bioequivalence of a newly developed 120 mg nifurtimox tablet formulation (Test treatment) compared with the 120 mg nifurtimox tablet currently used in the Bayer pediatric clinical development program (Reference treatment). The new tablet formulation assessed in this study is intended to replace the 120 mg nifurtimox tablet formulation currently used in clinical practice. It is an immediate-release tablet with an altered composition compared to the reference formulation. The new tablet overcomes pharmaceutical quality issues seen for the current formulation, e.g. sensitivity to humidity. Due to safety reasons, the study drug will be administered under fed conditions to adult male and female patients suffering from Chagas' disease and not healthy subjects (see also Benefit-risk assessment below).

In addition, the PK, safety, and tolerability of nifurtimox will be assessed as secondary objectives.


Condition or disease Intervention/treatment Phase
Bioequivalence Drug: Nifurtimox (Lampit, BAYA2502)_Test Drug: Nifurtimox (Lampit, BAYA2502)_Reference Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Open-label, Randomized, Single-dose, Cross-over Study to Assess Bioequivalence Between a Single 120 mg Nifurtimox Tablet and a Newly Developed 120 mg Nifurtimox Tablet, Administered Orally Under Fed Conditions to Adult Male and Female Patients With Chronic Chagas' Disease
Actual Study Start Date : December 5, 2018
Estimated Primary Completion Date : April 12, 2019
Estimated Study Completion Date : June 7, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chagas Disease

Arm Intervention/treatment
Experimental: Test Treatment + Reference Treatment

Male and female subjects with Chagas' disease will be give treatment follow below Crossover Sequence:

  1. Test treatment
  2. Reference treatment
Drug: Nifurtimox (Lampit, BAYA2502)_Test
Orally intake of 1 *120mg new formulation tablet as test treatment

Drug: Nifurtimox (Lampit, BAYA2502)_Reference
Orally intake of 1 *120mg current clinical formulation tablet as reference treatment

Experimental: Reference Treatment + Test Treatment

Male and female subjects with Chagas' disease will be give treatment follow below Crossover Sequence:

  1. Reference treatment
  2. Test treatment
Drug: Nifurtimox (Lampit, BAYA2502)_Test
Orally intake of 1 *120mg new formulation tablet as test treatment

Drug: Nifurtimox (Lampit, BAYA2502)_Reference
Orally intake of 1 *120mg current clinical formulation tablet as reference treatment




Primary Outcome Measures :
  1. AUC [ Time Frame: Pre-dose (up to 30 minutes before study drug administration), and at 15 minutes, 30 minutes, 45 minutes, and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 15 hours post-dose ]
    AUC:area under the concentration versus time curve from zero to infinity after single (first) dose

  2. AUC(0-tlast) [ Time Frame: Pre-dose (up to 30 minutes before study drug administration), and at 15 minutes, 30 minutes, 45 minutes, and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 15 hours post-dose ]
    AUC(0-tlast): AUC from time 0 to the last data point > LLOQ(lower limit of quantitation)

  3. Cmax [ Time Frame: Pre-dose (up to 30 minutes before study drug administration), and at 15 minutes, 30 minutes, 45 minutes, and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 15 hours post-dose ]
    Cmax: Maximum observed drug concentration in measured matrix after single dose administration


Secondary Outcome Measures :
  1. Time to reach Cmax (tmax) [ Time Frame: Pre-dose (up to 30 minutes before study drug administration), and at 15 minutes, 30 minutes, 45 minutes, and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 15 hours post-dose ]
  2. Half-life associated with terminal slope(t1/2) [ Time Frame: Pre-dose (up to 30 minutes before study drug administration), and at 15 minutes, 30 minutes, 45 minutes, and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 15 hours post-dose ]
  3. AUC divided by dose per body weight (AUCnorm) [ Time Frame: Pre-dose (up to 30 minutes before study drug administration), and at 15 minutes, 30 minutes, 45 minutes, and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 15 hours post-dose ]
  4. Cmax divided by dose per body weight (Cmax,norm) [ Time Frame: Pre-dose (up to 30 minutes before study drug administration), and at 15 minutes, 30 minutes, 45 minutes, and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 15 hours post-dose ]
  5. Number of participants with adverse events [ Time Frame: Up to 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Male/female patient 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.

  • Women and men of reproductive potential must agree to use adequate contraception when sexually active. This applies for the time period between signing of the informed consent form and 12 weeks after the last administration of study drug. The definition of adequate contraception will be based on the judgment of the investigator and on local requirements. Acceptable methods of contraception include, but are not limited to: (i) condoms (male or female) with or without a spermicidal agent; (ii) diaphragm or cervical cap with spermicide; (iii) intra-uterine device; (iv) hormone-based contraception. Subjects must agree to utilize two reliable and acceptable methods of contraception simultaneously.
  • Women of childbearing potential with confirmed last menstrual period by anamnesis and negative serum pregnancy test (beta-human chorionic gonadotropin [βhCG]) at screening and negative urine pregnancy test (βhCG) at pre-dose of each treatment.
  • Women of non-childbearing potential, such as surgically sterile women with either written documentation of surgical sterility or negative serum pregnancy test (βhCG) at screening and negative urine pregnancy test (βhCG) at pre-dose of each treatment.
  • Male subjects who agree not to act as sperm donors for 12 weeks after last administration of study drug.
  • Age: 18 to 45 years (inclusive) at screening.
  • Body mass index (BMI): ≥18 and <29.9 kg/m².
  • At least 3 months since delivery or abortion, or 3 months since cessation of lactation before screening.
  • Ability to understand and follow study-related instructions.

Exclusion Criteria

  • 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 drug (active substance or excipients of the preparations)
  • Suspected or known porphyria.
  • Clinically significant allergies (e.g. allergies affecting the lower respiratory tract such as allergic asthma or allergies requiring therapy with systemic corticosteroids) within 1 year.
  • Clinically significant non-allergic drug reactions, or multiple severe drug allergies (e.g. adverse reactions in the form of bronchospasm, asthma, rhinitis or urticaria after taking non-steroidal anti-inflammatory drugs).
  • Unstable or uncontrolled medical condition such as hypertension or diabetes, decompensated heart failure, 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.
  • Incompletely cured pre-existing diseases (except chronic Chagas' disease without active GI condition) for which it can be assumed that the absorption, distribution, metabolism, elimination, and effects of the study drugs will not be normal.
  • Febrile illness within 1 week before the first study drug administration.
  • Systolic blood pressure <100 or >140 mmHg (after resting in supine position for a minimum of 15 minutes).
  • Diastolic blood pressure <50 or >90 mmHg (after resting in supine position for a minimum of 15 minutes).
  • Heart rate <45
  • Positive pregnancy test.
  • Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), or human immunodeficiency virus antibodies (anti-HIV 1+2).
  • Positive urine drug screening.

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): NCT03708133


Contacts
Layout table for location contacts
Contact: Bayer Clinical Trials Contact (+) 1-888-8422937 clinical-trials-contact@bayer.com
Contact: For trial location information (Phone Menu Options '3' or '4') (+)1-888-84 22937

Locations
Layout table for location information
Argentina
FP Clinical Pharma Recruiting
Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina, C1425BAB
Sponsors and Collaborators
Bayer

Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03708133     History of Changes
Other Study ID Numbers: 19500
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:
New formulation

Additional relevant MeSH terms:
Layout table for MeSH terms
Nifurtimox
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents