PharmacokineticsPhase 1NCT02957435
Pharmacokinetics Study of Eplerenone Coated Tablets
A Phase 1 study testing eplerenone in people with Pharmacokinetics and Healthy Subjects, run by Biolab Sanus Farmaceutica at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the pharmacokinetics profile of the formulation of eplerenone coated tablets in the concentration of 25mg, 50mg and 100mg (2 coated tablets of 50mg) in male and female healthy subjects under fasting condition. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics, Healthy Subjects, Fasting
- What is being tested?
- eplerenone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2017to Dec 2017
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female subjects, with age between 18 and 50 years old;
- Body mass index (BMI) between 18.5 and 30 kg/m2;
- Good health conditions or without significant diseases, at investigator discretion, according to the protocol and evaluation performed such as: clinical history, vital signs, physical examination, electrocardiogram (ECG) and laboratory exams;
- Ability to understand the nature and the objective of the trial, including risks and adverse effects.
Who cannot join
- Know hypersensitivity to the investigational product (eplerenone) or chemically related compounds;
- History or presence of chronic hepatic or gastrointestinal diseases, or other condition that may interfere with drug absorption, distribution, metabolism or excretion;
- Be in use of maintenance therapy with any drugs that interferes with the investigational product, except oral contraceptives;
- History of hepatic, kidney, lungs, gastrointestinal, epileptic, hematologic, psychiatric diseases, hypertension of any etiology, history of myocardial infarction, angina and/or heart failure or malignant neoplasias, in other words, any current disease, acute or chronic, in monitoring or treatment;
- Electrocardiographic findings that at investigator discretion are not recommended for study participation;
- History of any cardiac surgery, kidney surgery (exeresis or kidney anegesis), intestinal (partial or full ablation of esophagus, stomach, duodenum, jejunum, ileum, ascending colon, transverse colon, descending colon, sigmoid or rectum) and liver or pancreas surgery;
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- Laboratory exams results out of the range considered normal in accordance with the reference ranges stipulated by the clinical laboratory, unless that are considered as not clinically significant by the investigator);
- Be a smoker;
- Ingestion of food that contains xanthine including more than five cups of coffee or tea per day;
- Vegan habits;
- History of abusive use of drugs and/or alcohol or excessive alcohol consumption;
- Have used regular medication in two weeks prior to start of treatment and the date of evaluation or have used any medication one week before, except contraceptives or in cases that, based on the half-life of the drug and/or active metabolites may be assumed the complete elimination;
- Have been hospitalized for any reason up to 8 weeks prior to start of the first period of trial treatment;
- Have received any treatment with any drug with known and well-established toxic potential to major organs inside of the 3 months prior to the study;
- Have participated from any experimental trial or have ingested any investigational drug within 12 months prior to the trial start;
- Be pregnant or in breastfeeding period or want to get pregnant during the study period;
- Have donated or have lost 450 mL or more of blood within 3 months prior to the trial or donation of more than 1500 mL of blood within 12 months prior to the trial;
- Have any condition, that prohibits the subject to participate in the trial, at the investigator's discretion;
- Have difficulty to swallow medicines and/or approximately 200 mL of water at the morning;
- Inability to keep awake or seated during one hour or necessary time at investigator discretion;
- Present a positive pregnancy test;
- Present breathalyzer test higher than zero;
- Present a positive result for a preliminary test of drugs.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
CAEP - Centro Avançado de Estudos e Pesquisas Ltda.
Campinas, São Paulo, 13087567
About this study
Official title: Phase I, Open-label, Three Periods Study in Health Male and Female Subjects, Under Fasting Condition for Evaluation of Pharmacokinetics Profile of Single Dose of Eplerenone in Coated Tablets Formulation on Concentrations of 25mg, 50mg and 100mg, Produced by Biolab Sanus Farmacêutica Ltda
The purpose of this study is to evaluate the pharmacokinetics profile of the formulation of eplerenone coated tablets in the concentration of 25mg, 50mg and 100mg (2 coated tablets of 50mg) in male and female healthy subjects under fasting condition.
Read the detailed description
This is a phase I study of eplerenone coated tablets of 25mg, 50mg and 100mg (2 coated tablets of 50mg) in fasting administration. Sample size is 12 subjects, male and female, aged between 18 and 50 years old.
This is an open-label, unicenter study with three periods, three treatments and one sequence. Each subject will receive the following treatments at the following periods:
- Period 1: one coated tablet of eplerenone 25mg in fasting
- Period 2: one coated tablet of eplerenone 50mg in fasting
- Period 3: two coated tablets of eplerenone 50mg (100mg of eplerenone) in fasting Formulations will be administered in a single dose, orally in each period. Trial subjects will be admitted in three different periods of 24 hours each, when investigational product will be administered and blood samples will be collected at pre-determined periods of time for pharmacokinetics evaluation.
Primary objective is to evaluate the pharmacokinetics of formulations of eplerenone coated tablets of 25mg, 50mg and 100mg (two coated tablets of 50mg) in healthy subjects under fasting condition. As a secondary objective, it will be also evaluated the safe and tolerability of coated tablets of eplerenone.
- Conditions
- Pharmacokinetics, Healthy Subjects, Fasting
- Being tested
- eplerenone
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eplerenoneDrug
(Single arm) Sequence 1: one eplerenone coated tablet 25 mg in fasting (period 1), one eplerenone coated tablet 50 mg in fasting (period 2) and two eplerenone coated tablets 50 mg (100 mg of eplerenone) in fasting (period 3)
| Study group | Role | What they receive |
|---|---|---|
| eplerenone | Experimental | (Single arm) Sequence 1: one eplerenone coated tablet 25 mg in fasting (period 1), one eplerenone coated tablet 50 mg in fasting (period 2) and two eplerenone coated tablets 50 mg (100 mg of eplerenone) in fasting (period 3) Receives: Drug: eplerenone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum serum concentration (Cmax)
Measured: 24 hours
Area under the curve (ASCo-t)
Measured: 24 hours
Secondary outcomes (7)
Time to reach Cmax (Tmax)
Measured: 24 hours
Half-life (t1/2)
Measured: 24 hours
Elimination constant rate (Kel)
Measured: 24 hours
Area under the curve (0-inf)
Measured: 24 hours
Number of adverse events
Measured: 30 days
Intensity of adverse events
Measured: 30 days
Causality of adverse events
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study startJul 2017 (estimated)
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Why it stopped: Study has been cancelled and it has not been initiated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biolab Sanus Farmaceutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pedro S Junior, MD, Principal investigator, CAEP - Centro Avançado de Estudos e Pesquisa Ltda.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02957435
- Sponsor's protocol ID
- CAEP 56.005.16
- Status last verified
- May 2018
- First submitted
- 3 Nov 2016
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Open-label, Three Periods Study in Health Male and Female Subjects, Under Fasting Condition for Evaluation of Pharmacokinetics Profile of Single Dose of Eplerenone in Coated Tablets Formulation on Concentrations of 25mg, 50mg and 100mg, Produced by Biolab Sanus Farmacêutica Ltda
- ClinicalTrials.gov ID
- NCT02957435
- Acronym / sponsor ID
- CAEP 56.005.16
- Conditions
- Pharmacokinetics, Healthy Subjects, Fasting
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study has been cancelled and it has not been initiated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Biolab Sanus FarmaceuticaIndustry (pharma, biotech, devices)
- Study start
- Jul 2017 (estimated)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 7 Nov 2016 (estimated)
- 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 purpose of this study is to evaluate the pharmacokinetics profile of the formulation of eplerenone coated tablets in the concentration of 25mg, 50mg and 100mg (2 coated tablets of 50mg) in male and female healthy subjects under fasting condition.
Detailed description
This is a phase I study of eplerenone coated tablets of 25mg, 50mg and 100mg (2 coated tablets of 50mg) in fasting administration. Sample size is 12 subjects, male and female, aged between 18 and 50 years old.
This is an open-label, unicenter study with three periods, three treatments and one sequence. Each subject will receive the following treatments at the following periods:
- Period 1: one coated tablet of eplerenone 25mg in fasting
- Period 2: one coated tablet of eplerenone 50mg in fasting
- Period 3: two coated tablets of eplerenone 50mg (100mg of eplerenone) in fasting Formulations will be administered in a single dose, orally in each period. Trial subjects will be admitted in three different periods of 24 hours each, when investigational product will be administered and blood samples will be collected at pre-determined periods of time for pharmacokinetics evaluation.
Primary objective is to evaluate the pharmacokinetics of formulations of eplerenone coated tablets of 25mg, 50mg and 100mg (two coated tablets of 50mg) in healthy subjects under fasting condition. As a secondary objective, it will be also evaluated the safe and tolerability of coated tablets of eplerenone.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| eplerenone | Experimental | Drug: eplerenone(Single arm) Sequence 1: one eplerenone coated tablet 25 mg in fasting (period 1), one eplerenone coated tablet 50 mg in fasting (period 2) and two eplerenone coated tablets 50 mg (100 mg of eplerenone) in fasting (period 3) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female subjects, with age between 18 and 50 years old;
- Body mass index (BMI) between 18.5 and 30 kg/m2;
- Good health conditions or without significant diseases, at investigator discretion, according to the protocol and evaluation performed such as: clinical history, vital signs, physical examination, electrocardiogram (ECG) and laboratory exams;
- Ability to understand the nature and the objective of the trial, including risks and adverse effects.
Key exclusion criteria (23 listed)
- Know hypersensitivity to the investigational product (eplerenone) or chemically related compounds;
- History or presence of chronic hepatic or gastrointestinal diseases, or other condition that may interfere with drug absorption, distribution, metabolism or excretion;
- Be in use of maintenance therapy with any drugs that interferes with the investigational product, except oral contraceptives;
- History of hepatic, kidney, lungs, gastrointestinal, epileptic, hematologic, psychiatric diseases, hypertension of any etiology, history of myocardial infarction, angina and/or heart failure or malignant neoplasias, in other words, any current disease, acute or chronic, in monitoring or treatment;
- Electrocardiographic findings that at investigator discretion are not recommended for study participation;
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 |
|---|---|---|
| eplerenone(Single arm) Sequence 1: one eplerenone coated tablet 25 mg in fasting (period 1), one eplerenone coated tablet 50 mg in fasting (period 2) and two eplerenone coated tablets 50 mg (100 mg of eplerenone) in fasting (period 3) | Drug | eplerenone |
Primary outcome
Maximum serum concentration (Cmax)
Time frame: 24 hours
Area under the curve (ASCo-t)
Time frame: 24 hours
7 secondary outcomes
Time to reach Cmax (Tmax)
Time frame: 24 hours
Half-life (t1/2)
Time frame: 24 hours
Elimination constant rate (Kel)
Time frame: 24 hours
Area under the curve (0-inf)
Time frame: 24 hours
Number of adverse events
Time frame: 30 days
Intensity of adverse events
Time frame: 30 days
Causality of adverse events
Time frame: 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- Individual participant dataSharing planned: No
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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.
Pedro S Junior, MD principal investigator
CAEP - Centro Avançado de Estudos e Pesquisa Ltda.
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 eplerenone in people with Pharmacokinetics and Healthy Subjects, run by Biolab Sanus Farmaceutica at 1 site in Brazil.
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 4 inclusion and 23 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: withdrawn, as of the sponsor's last update on 6 Jun 2018. 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 Brazil. 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 was withdrawn before enrolling participants, so there are no results.
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?
Maximum serum concentration (Cmax) (time frame: 24 hours). The study lists 2 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 6 Jun 2018.