HealthyPhase 1NCT02505191
Pilot Pharmacokinetic Study of a Prolonged-release Formulation of St. John's Wort Extract Ze 117
A Phase 1 study testing St. John's wort prolonged-release tablet 500 mg and St. John's wort film coated tablets 250 mg in people with Healthy, run by Max Zeller Soehne AG at 1 site in Germany.
Trial summary
A pilot phase I, randomised, open mono-center, two parallel group clinical trial investigating the pharmacokinetics of a prolonged-release formulation in comparison to an immediate-release formulation of St. John's wort extract Ze 117 in healthy male volunteers under fasting condition. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- St. John's wort prolonged-release tablet 500 mg and St. John's wort film coated tablets 250 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2015to Nov 2015
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Caucasian male volunteers
- Physically and mentally healthy as judged by means of a medical and standard laboratory examination
- BMI of between 19 and 29 kg/m2, inclusively
- Weight not exceeding 90 kg
- Non-smokers (confirmed by urine cotinine test)
- Informed cConsent as documented by signature
Who cannot join
- Known or suspected hypersensitivity to any ingredient of the investigational medicinal product
- Any clinically significant illnesses or clinically significant surgery within 1 year prior to the administration of the study medication
- Any surgical or medical condition which might interfere with absorption, distribution, metabolism or excretion of the drug
- Any clinically significant abnormality or abnormal laboratory test results, as judged by the investigator found during the medical screening
- Positive test of hepatitis B, hepatitis C or HIV screening (HIV antibody, Hepatitis B (HBsAg), Hepatitis C (HCV)
- ECG abnormalities (clinical significant) or vital signs abnormalities (systolic blood pressure lower than 90 or over 145 mmHg, diastolic blood pressure lower than 60 or over 95 mmHg, or heart rate less than 45 or over 100bpm) at screening
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- History of asthma or obstructive pulmonary disease (e.g.COPD)
- Known photohypersensitivity.
- Presents or history of alcohol dependence within the last year (> 40 g ethanol/d or more than 10 units per weeks (1unit=150 ml of wine or 360 ml of beer or 45 ml alcohol 45%))
- History of drug dependence or positive results of drug screen
- Concomitant participation in another clinical trial within the 4 weeks prior to the planned first drug administration.
- Donation of blood or blood products within 30 days prior to the planned first drug administration.
- Treatment with any medication or topical drugs with systemic action used in the past 4 weeks, prior to the planned first drug administration ,or 6 times the half-life of the respective drug, whatever is longer (excluding single use of paracetamol or ibuprofen up to 24 hours prior to the planned first drug administration).
- Suspected inability, e.g. language problems, or known or suspected non-compliance, e.g. non-willingness to fulfil the dietary restrictions
- Difficulty to swallow study medication
- Enrolment of the investigator, his/her family members, employees and other dependent persons
- Any reason which, in the opinion of the Investigator, would prevent the subject from participating the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Phase I, Randomised, Open Mono-center, Multiple Dose, Two Parallel Groups Clinical Trial Investigating the Pharmacokinetics of a Prolonged-release Formulation in Comparison to an Immediate-release Formulation of St. John's Wort Extract Ze 117 in Healthy Male Volunteers Under Fasting Condition
A pilot phase I, randomised, open mono-center, two parallel group clinical trial investigating the pharmacokinetics of a prolonged-release formulation in comparison to an immediate-release formulation of St. John's wort extract Ze 117 in healthy male volunteers under fasting condition.
- Conditions
- Healthy
- Being tested
- St. John's wort prolonged-release tablet 500 mg, St. John's wort film coated tablets 250 mg
- Keywords
- Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
St. John's wort prolonged-release tablet 500 mgDrug
Also called Prolonged-release formulation
St. John's wort film coated tablets 250 mgDrug
Also called Immediate-release formulation
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | St. John's wort prolonged-release tablet 500 mg Receives: Drug: St. John's wort prolonged-release tablet 500 mg |
| Reference | Active comparator | St. John's wort film coated tablets 250 mg (Remotiv N) Receives: Drug: St. John's wort film coated tablets 250 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Half Value Duration (HVD) of surrogate markers of the total extract Ze 117
Measured: 3 days
Secondary outcomes (9)
Peak-trough fluctuation (PTF) of surrogate markers of the total extract Ze 117
Measured: 3 days
Tmax of surrogate markers of the total extract Ze 117
Measured: 3 days
AUCss of surrogate markers of the total extract Ze 117
Measured: 3 days
Cmax of surrogate markers of the total extract Ze 117
Measured: 3 days
Cmin of surrogate markers of the total extract Ze 117
Measured: 3 days
lag time of surrogate markers of the total extract Ze 117
Measured: 3 days
Mean Residence Time (MRT) of surrogate markers of the total extract Ze 117
Measured: 3 days
T1/2 of surrogate markers of the total extract Ze 117
Measured: 3 days
Half value Duration (HVD) of hyperforin
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startNov 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Max Zeller Soehne AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02505191
- Sponsor's protocol ID
- Ze117-1-2014-01a
- Status last verified
- Jan 2016
- First submitted
- 22 Jun 2015
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Phase I, Randomised, Open Mono-center, Multiple Dose, Two Parallel Groups Clinical Trial Investigating the Pharmacokinetics of a Prolonged-release Formulation in Comparison to an Immediate-release Formulation of St. John's Wort Extract Ze 117 in Healthy Male Volunteers Under Fasting Condition
- ClinicalTrials.gov ID
- NCT02505191
- Acronym / sponsor ID
- Ze117-1-2014-01a
- Conditions
- Healthy
- Keywords
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Max Zeller Soehne AGIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 22 Jul 2015 (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.
A pilot phase I, randomised, open mono-center, two parallel group clinical trial investigating the pharmacokinetics of a prolonged-release formulation in comparison to an immediate-release formulation of St. John's wort extract Ze 117 in healthy male volunteers under fasting condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Drug: St. John's wort prolonged-release tablet 500 mgSt. John's wort prolonged-release tablet 500 mg |
| Reference | Active comparator | Drug: St. John's wort film coated tablets 250 mgSt. John's wort film coated tablets 250 mg (Remotiv N) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Caucasian male volunteers
- Physically and mentally healthy as judged by means of a medical and standard laboratory examination
- BMI of between 19 and 29 kg/m2, inclusively
- Weight not exceeding 90 kg
- Non-smokers (confirmed by urine cotinine test)
Key exclusion criteria (17 listed)
- Known or suspected hypersensitivity to any ingredient of the investigational medicinal product
- Any clinically significant illnesses or clinically significant surgery within 1 year prior to the administration of the study medication
- Any surgical or medical condition which might interfere with absorption, distribution, metabolism or excretion of the drug
- Any clinically significant abnormality or abnormal laboratory test results, as judged by the investigator found during the medical screening
- Positive test of hepatitis B, hepatitis C or HIV screening (HIV antibody, Hepatitis B (HBsAg), Hepatitis C (HCV)
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 |
|---|---|---|
| St. John's wort prolonged-release tablet 500 mgAlso: Prolonged-release formulation | Drug | Test |
| St. John's wort film coated tablets 250 mgAlso: Immediate-release formulation | Drug | Reference |
Primary outcome
Half Value Duration (HVD) of surrogate markers of the total extract Ze 117
Time frame: 3 days
9 secondary outcomes
Peak-trough fluctuation (PTF) of surrogate markers of the total extract Ze 117
Time frame: 3 days
Tmax of surrogate markers of the total extract Ze 117
Time frame: 3 days
AUCss of surrogate markers of the total extract Ze 117
Time frame: 3 days
Cmax of surrogate markers of the total extract Ze 117
Time frame: 3 days
Cmin of surrogate markers of the total extract Ze 117
Time frame: 3 days
lag time of surrogate markers of the total extract Ze 117
Time frame: 3 days
Mean Residence Time (MRT) of surrogate markers of the total extract Ze 117
Time frame: 3 days
T1/2 of surrogate markers of the total extract Ze 117
Time frame: 3 days
Half value Duration (HVD) of hyperforin
Time frame: 3 days
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 31 Jan 2017.
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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 St. John's wort prolonged-release tablet 500 mg and St. John's wort film coated tablets 250 mg in people with Healthy, run by Max Zeller Soehne AG at 1 site in Germany.
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 6 inclusion and 17 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 31 Jan 2017. 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 Germany. 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?
Half Value Duration (HVD) of surrogate markers of the total extract Ze 117 (time frame: 3 days). 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 31 Jan 2017.