BioequivalencePhase 1NCT03708133
Study to Assess Bioequivalence of a New Nifurtimox Oral Tablet Formulation
A Phase 1 study testing Nifurtimox (Lampit, BAYA2502)_Test and Nifurtimox (Lampit, BAYA2502)_Reference in people with Bioequivalence, run by Bayer at 1 site in Argentina.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Bioequivalence
- What is being tested?
- Nifurtimox (Lampit, BAYA2502)_Test and Nifurtimox (Lampit, BAYA2502)_Reference
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteArgentina
- Study dates
- 5 Dec 2018to 18 Jun 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Argentina1 site
FP Clinical Pharma
Buenos Aires, Ciudad Auton. de Buenos Aires, C1425BAB
About this study
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
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.
- Conditions
- Bioequivalence
- Being tested
- Nifurtimox (Lampit, BAYA2502)_Test, Nifurtimox (Lampit, BAYA2502)_Reference
- Keywords
- New formulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nifurtimox (Lampit, BAYA2502)_TestDrug
Orally intake of 1 *120mg new formulation tablet as test treatment
Nifurtimox (Lampit, BAYA2502)_ReferenceDrug
Orally intake of 1 *120mg current clinical formulation tablet as reference treatment
| Study group | Role | What they receive |
|---|---|---|
| Test Treatment + Reference Treatment | Experimental | Male and female subjects with Chagas' disease will be give treatment follow below Crossover Sequence:
1. Test treatment
2. Reference treatment Receives: Drug: Nifurtimox (Lampit, BAYA2502)_Test; Drug: Nifurtimox (Lampit, BAYA2502)_Reference |
| Reference Treatment + Test Treatment | Experimental | Male and female subjects with Chagas' disease will be give treatment follow below Crossover Sequence:
1. Reference treatment
2. Test treatment Receives: Drug: Nifurtimox (Lampit, BAYA2502)_Test; Drug: Nifurtimox (Lampit, BAYA2502)_Reference |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of nifurtimox in plasma
AUC:area under the concentration versus time curve from zero to infinity after single (first) dose
Measured: 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) of nifurtimox in plasma
AUC(0-tlast): AUC from time 0 to the last data point > LLOQ(lower limit of quantitation)
Measured: 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 of nifurtimox in plasma
Cmax: Maximum observed drug concentration in measured matrix after single dose administration
Measured: 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
Secondary outcomes (5)
tmax of nifurtimox in plasma
tmax: time to reach Cmax
Measured: 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
t1/2 of nifurtimox in plasma
t1/2: Half-life associated with terminal slope
Measured: 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
AUCnorm of nifurtimox in plasma
AUCnorm: AUC divided by dose per body weight
Measured: 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,norm of nifurtimox in plasma
Cmax,norm: Cmax divided by dose per body weight
Measured: 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
Number of participants with treatment emergent adverse events
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start5 Dec 2018
- Primary completion17 Apr 2019
- Study completion18 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioequivalenceStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03708133
- Sponsor's protocol ID
- 19500
- Status last verified
- Jun 2020
- First submitted
- 12 Oct 2018
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03708133
- Acronym / sponsor ID
- 19500
- Conditions
- Bioequivalence
- Keywords
- New formulation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 5 Dec 2018 (actual)
- Primary completion
- 17 Apr 2019 (actual)
- Study completion
- 18 Jun 2019 (actual)
- First posted
- 17 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Treatment + Reference Treatment | Experimental | Drug: Nifurtimox (Lampit, BAYA2502)_Test, Drug: Nifurtimox (Lampit, BAYA2502)_ReferenceMale and female subjects with Chagas' disease will be give treatment follow below Crossover Sequence: 1. Test treatment 2. Reference treatment |
| Reference Treatment + Test Treatment | Experimental | Drug: Nifurtimox (Lampit, BAYA2502)_Test, Drug: Nifurtimox (Lampit, BAYA2502)_ReferenceMale and female subjects with Chagas' disease will be give treatment follow below Crossover Sequence: 1. Reference treatment 2. Test treatment |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (14 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nifurtimox (Lampit, BAYA2502)_TestOrally intake of 1 *120mg new formulation tablet as test treatment | Drug | Reference Treatment + Test Treatment, Test Treatment + Reference Treatment |
| Nifurtimox (Lampit, BAYA2502)_ReferenceOrally intake of 1 *120mg current clinical formulation tablet as reference treatment | Drug | Reference Treatment + Test Treatment, Test Treatment + Reference Treatment |
Primary outcome
AUC of nifurtimox in plasma
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
AUC(0-tlast) of nifurtimox in plasma
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)
Cmax of nifurtimox in plasma
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
5 secondary outcomes
tmax of nifurtimox in plasma
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
t1/2 of nifurtimox in plasma
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
AUCnorm of nifurtimox in plasma
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,norm of nifurtimox in plasma
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
Number of participants with treatment emergent adverse events
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nifurtimox (Lampit, BAYA2502)_Test and Nifurtimox (Lampit, BAYA2502)_Reference in people with Bioequivalence, run by Bayer at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC of nifurtimox in plasma (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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.