Heart FailurePhase 1NCT02252692
Relative Bioavailability Study With Enalapril in Healthy Volunteers
A Phase 1 study testing Enalapril in people with Heart Failure, run by Ethicare GmbH at 1 site in Belgium.
Trial summary
Phase I study in healthy adult male and female volunteers to compare the bioavailability of enalapril administered in orodispersible Minitablets with or without water in comparison to the standard galenic tablet formulation of enalapril. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Enalapril
- 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 siteBelgium
- Study dates
- Aug 2014to Oct 2014
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female subjects aged between 18 and 55 years, inclusive.
- Body mass index (BMI) between 18.5 and 30 kg/m2 inclusive (BMI = weight/height2).
- Non-smoker (not smoked for at least 3 months prior to screening).
- Physical examinations, clinical laboratory values, vital signs and ECGs are clinically acceptable to the investigator.
- Subjects must have signed an informed consent document indicating that they understand the purpose of, and procedures required for the study and are willing to participate in the study and comply with the study procedures and restrictions.
Who cannot join
- History or evidence of clinically significant disorder (including psychiatric), condition or disease that, in the opinion of the investigator would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
- Women who are lactating/breastfeeding.
- Women planning to become pregnant during the duration of the study.
- Men with pregnant partners or whose partners plan to become pregnant during the study.
- Positive pregnancy test (women) on screening or predose.
- A baseline systolic BP ≥ 140 or < 90 mmHg and/or a baseline diastolic BP of ≥ 90 or <50 mmHg. A baseline ECG QTcB > 440 ms (males) or >450 ms (females) or heart rate >100 bpm.
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- Positive for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen, or hepatitis C antibodies at screening.
- Known substance abuse (eg, alcohol, illicit or illegal drugs) within 1 year of dosing.
- Positive test for drug or alcohol use at screening. If the retest during the screening period is negative, subject can be included.
- Inability or unwillingness to refrain from alcohol consumption 24 hours prior to study visits and to limit consumption throughout the course of the study.
- Has had major surgery, donated or lost 500 mL or more of blood within 2 months of the first study treatment or has a history of chronic anemia.
- Receiving or has received any investigational drug (or is currently using an investigational drug or device) within 30 days or 5 half-lives (whichever is longer), prior to receiving the first study treatment.
- Use of any over-the-counter or prescription medications within 7 days or 5 half-lives (whichever is longer), prior to receiving the first study treatment. However, if a subject has to use medication within 7 days of the first study drug administration, he/she can be included in the study the study if according to the investigator the medication is not relevant within the context of the trial. Paracetamol (up to 2 g per day) for analgesia, and hormonal birth control medication will be allowed.
- Use of any herbal medicines (eg. St. John's wort), vitamins, and supplements consumed by the subject within 7 days prior to receiving the first study treatment. However, if a subject has used herbal medicines (eg, St. John's wort), vitamins, and supplements medication within 7 days of the first study drug administration, he/she can be included in the study if according to the investigator the medication is not relevant within the context of the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relative Bioavailability of Enalapril Administered as Orodispersible Minitablets in Healthy Adults
Phase I study in healthy adult male and female volunteers to compare the bioavailability of enalapril administered in orodispersible Minitablets with or without water in comparison to the standard galenic tablet formulation of enalapril. The standard pharmacokinetic parameters will be calculated from the bioanalytical results for enalapril and enalaprilat and compared in a descriptive statistical analysis.
Read the detailed description
Trial design: Open label, randomized, 3-way cross-over, 3-treatments, 3-periods in 24 healthy male and female adult subjects.
Primary objectives:
- To assess the relative bioavailability of 10 mg enalapril administered as orodispersible minitablets (ODMT) with water versus a standard enalapril tablet formulation (reference product: Renitec® 2 x 5 mg tablets) taken with water;
- To assess the relative bioavailability of 10 mg enalapril administered as orodispersible minitablets (ODMT) dispersed in the oral cavity versus a standard enalapril tablet formulation (reference product: Renitec® 2 x 5 mg tablets) taken with water.
Secondary objectives:
- To assess whether the PK of enalapril is affected when the orodispersible minitablet (ODMT) is entirely swallowed with water versus dispersion in the oral cavity.
- To assess the general safety and tolerability including local tolerability and palatability of enalapril administered as orodispersible minitablet (ODMT).
- Conditions
- Heart Failure
- Being tested
- Enalapril
- Keywords
- Bioavailability, pharmacokinetics, enalapril, enalaprilat
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnalaprilDrug
Also called Renitec
oral administration
| Study group | Role | What they receive |
|---|---|---|
| Enalapril | Active comparator | Renitec® 2 x 5 mg tablets administered at once, to be entirely swallowed with 240 ml water Receives: Drug: Enalapril |
| Enalapril ODMT | Experimental | 10 x 1mg of Enalapril ODMT, swallowed entirely with 240ml of water Receives: Drug: Enalapril |
| Enalapril ODMT dispersed | Experimental | 10 x 1mg of Enalapril ODMT, dispersed on tongue Receives: Drug: Enalapril |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC 0-∞
Area under the serum concentration-time curve from time of administration to infinite time for enalaprilat
Measured: predose, 10 min, 20 min, 30 min, 45 min, 1 hour, 1.25 hours,1.5 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 4.5 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose
Secondary outcomes (10)
Safety parameters
adverse events
Measured: 0-48 hours post dose, at follow-up visit
Tolerability Outcome Parameter
orodispersible minitablet palatability questionnaire
Measured: Immediately and 10 minutes after orodispersible minitablet administration
AUC 0-∞
Area under the serum-concentration time curve from time of administration extrapolated to infinite time for enalapil
Measured: predose, 10 min, 20 min, 30 min, 45 min, 1 hour, 1.25 hours,1.5 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 4.5 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose
AUC 0-t
Area under the serum concentration-time curve from from administration to the last measurable concentration or last sampling time point (48h) for enalapril
Measured: predose, 10 min, 20 min, 30 min, 45 min, 1 hour, 1.25 hours,1.5 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 4.5 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose
AUC 0-t
Area under the serum concentration-time curve from from administration to the last measurable concentration or last sampling time point (48h) for enalaprilat
Measured: predose, 10 min, 20 min, 30 min, 45 min, 1 hour, 1.25 hours,1.5 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 4.5 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose
Cmax
Maximum serum concentration for enalapril
Measured: predose, 10 min, 20 min, 30 min, 45 min, 1 hour, 1.25 hours,1.5 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 4.5 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose
Cmax
Maximum serum concentration of enalaprilat
Measured: predose, 10 min, 20 min, 30 min, 45 min, 1 hour, 1.25 hours,1.5 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 4.5 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose
tmax
Time of maximum serum concentration of enalapril
Measured: predose, 10 min, 20 min, 30 min, 45 min, 1 hour, 1.25 hours,1.5 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 4.5 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose
tmax
Time of maximum serum concentration for enalaprilat
Measured: predose, 10 min, 20 min, 30 min, 45 min, 1 hour, 1.25 hours,1.5 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 4.5 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose
Ae
Amount of enalaprilat or the sum of enalapril and enalaprilat excreted in urine over the time interval 0-t
Measured: 0-2, 2-4, 4-8, 8-12, 12-24, 24-36, 36-48 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionOct 2014 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ethicare GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- European Commission
- Responsible party
- Sponsor
- Investigators
- Jan De Hoon, Professor, Principal investigator, Center of Clinical Pharmacology, University Hospital Leuven, Leuven, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02252692
- Sponsor's protocol ID
- 2014-000956-28
- Other IDs
- 2014
- Status last verified
- Sep 2014
- First submitted
- 6 Sep 2014
- Last updated
- 30 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Bioavailability of Enalapril Administered as Orodispersible Minitablets in Healthy Adults
- ClinicalTrials.gov ID
- NCT02252692
- Acronym / sponsor ID
- 2014-000956-28
- Conditions
- Heart Failure
- Keywords
- Bioavailability, pharmacokinetics, enalapril, enalaprilat
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Ethicare GmbHIndustry (pharma, biotech, devices)
- Collaborators
- European Commission
- Study start
- Aug 2014
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 30 Sep 2014 (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.
Phase I study in healthy adult male and female volunteers to compare the bioavailability of enalapril administered in orodispersible Minitablets with or without water in comparison to the standard galenic tablet formulation of enalapril. The standard pharmacokinetic parameters will be calculated from the bioanalytical results for enalapril and enalaprilat and compared in a descriptive statistical analysis.
Detailed description
Trial design: Open label, randomized, 3-way cross-over, 3-treatments, 3-periods in 24 healthy male and female adult subjects.
Primary objectives:
- To assess the relative bioavailability of 10 mg enalapril administered as orodispersible minitablets (ODMT) with water versus a standard enalapril tablet formulation (reference product: Renitec® 2 x 5 mg tablets) taken with water;
- To assess the relative bioavailability of 10 mg enalapril administered as orodispersible minitablets (ODMT) dispersed in the oral cavity versus a standard enalapril tablet formulation (reference product: Renitec® 2 x 5 mg tablets) taken with water.
Secondary objectives:
- To assess whether the PK of enalapril is affected when the orodispersible minitablet (ODMT) is entirely swallowed with water versus dispersion in the oral cavity.
- To assess the general safety and tolerability including local tolerability and palatability of enalapril administered as orodispersible minitablet (ODMT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Enalapril | Active comparator | Drug: EnalaprilRenitec® 2 x 5 mg tablets administered at once, to be entirely swallowed with 240 ml water |
| Enalapril ODMT | Experimental | Drug: Enalapril10 x 1mg of Enalapril ODMT, swallowed entirely with 240ml of water |
| Enalapril ODMT dispersed | Experimental | Drug: Enalapril10 x 1mg of Enalapril ODMT, dispersed on tongue |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male and female subjects aged between 18 and 55 years, inclusive.
- Body mass index (BMI) between 18.5 and 30 kg/m2 inclusive (BMI = weight/height2).
- Non-smoker (not smoked for at least 3 months prior to screening).
- Physical examinations, clinical laboratory values, vital signs and ECGs are clinically acceptable to the investigator.
- Subjects must have signed an informed consent document indicating that they understand the purpose of, and procedures required for the study and are willing to participate in the study and comply with the study procedures and restrictions.
Key exclusion criteria (14 listed)
- History or evidence of clinically significant disorder (including psychiatric), condition or disease that, in the opinion of the investigator would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
- Women who are lactating/breastfeeding.
- Women planning to become pregnant during the duration of the study.
- Men with pregnant partners or whose partners plan to become pregnant during the study.
- Positive pregnancy test (women) on screening or predose.
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 |
|---|---|---|
| EnalaprilAlso: Renitecoral administration | Drug | Enalapril, Enalapril ODMT, Enalapril ODMT dispersed |
Primary outcome
AUC 0-∞
Time frame: predose, 10 min, 20 min, 30 min, 45 min, 1 hour, 1.25 hours,1.5 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 4.5 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose
Area under the serum concentration-time curve from time of administration to infinite time for enalaprilat
10 secondary outcomes
Safety parameters
Time frame: 0-48 hours post dose, at follow-up visit
Tolerability Outcome Parameter
Time frame: Immediately and 10 minutes after orodispersible minitablet administration
AUC 0-∞
Time frame: predose, 10 min, 20 min, 30 min, 45 min, 1 hour, 1.25 hours,1.5 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 4.5 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose
AUC 0-t
Time frame: predose, 10 min, 20 min, 30 min, 45 min, 1 hour, 1.25 hours,1.5 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 4.5 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose
AUC 0-t
Time frame: predose, 10 min, 20 min, 30 min, 45 min, 1 hour, 1.25 hours,1.5 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 4.5 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose
Cmax
Time frame: predose, 10 min, 20 min, 30 min, 45 min, 1 hour, 1.25 hours,1.5 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 4.5 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose
Cmax
Time frame: predose, 10 min, 20 min, 30 min, 45 min, 1 hour, 1.25 hours,1.5 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 4.5 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose
tmax
Time frame: predose, 10 min, 20 min, 30 min, 45 min, 1 hour, 1.25 hours,1.5 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 4.5 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose
tmax
Time frame: predose, 10 min, 20 min, 30 min, 45 min, 1 hour, 1.25 hours,1.5 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 4.5 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose
Ae
Time frame: 0-2, 2-4, 4-8, 8-12, 12-24, 24-36, 36-48 hours post-dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2014.
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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.
Jan De Hoon, Professor principal investigator
Center of Clinical Pharmacology, University Hospital Leuven, Leuven, Belgium
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 Enalapril in people with Heart Failure, run by Ethicare GmbH at 1 site in Belgium.
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 5 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: status not confirmed, as of the sponsor's last update on 30 Sep 2014. 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 Belgium. 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?
Results are not available in the source record.
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 0-∞ (time frame: predose, 10 min, 20 min, 30 min, 45 min, 1 hour, 1.25 hours,1.5 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 4.5 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose). 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 30 Sep 2014.