HealthyPhase 1NCT02191241
Pharmacokinetics of a Single Oral Dose of 1,800 mg Red Vine Leaf Extract (Antistax®)
A Phase 1 study testing Red Vine Leaf Extract in people with Healthy, run by Boehringer Ingelheim.
Trial summary
To describe the plasma and urinary pharmacokinetics of quercetin glucuronide and kaempferol glucuronide after the administration of a single peroral dose of 1,800mg Red Vine Leaf Extract (Antistax®). Additionally, the trial evaluated the safety and tolerability of this dose in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Red Vine Leaf Extract
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Aug 2001to Sep 2004
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- male or female (if female: either of non-childbearing potential or taking adequate contraceptive measures)
- caucasian
- age: 18 to 40 years old
- body mass index (BMI): 18-28 kg x m-2
- subjects who - on the basis of extensive pre-trial investigation - could be considered to be healthy
- subjects who were willing and capable to confirm written consent to enrolment after ample information has been provided
Who cannot join
- if female: positive pregnancy test upon recruitment
- subjects with any relevant clinical abnormality (as based on extensive medical history, physical examination, vital signs)
- subjects with chronic or relevant acute infections
- subjects with therapy-requiring allergies (including drug allergies)
- subjects with suspicion of hypersensitivity to the investigational medication
- subjects with any clinically relevant laboratory abnormality (including positive results for hepatitis and HIV serology)
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- subjects who had received any medication within 1 week prior to trial start or during the trial, except for hormonal contraceptives (females) or thyroid hormone replacement after thyroidectomy
- subjects who had taken a drug with a long half-life (≥ 24 hours) within one month before enrolment in the trial
- subjects who participated in a trial with a novel investigational medication within the last 8 weeks before the start of the present trial
- subjects who participated in a trial with a registered compound within the last 4 weeks before the start of the present trial
- subjects who donated blood or plasma within the last 4 weeks before the start of the present trial
- subjects who smoked more than 15 cigarettes per day and subjects who were not willing or able to abstain from smoking from 12:00 hours before and during the profiling days
- subjects known or suspected to be (social) drug dependent, incl. those drinking more than 60 g alcohol per day and who were not willing to abstain from alcohol during the active trial phase
- subjects adhering to a diet (i.e. vegetarian) or lifestyle (including extreme physical activities such as competitive sports and weight lifting) that might interfere with the investigation
- subjects known or suspected not to comply with the trial directives and/or known or suspected not to be reliable or trustworthy
- subjects known or suspected not to be capable of understanding and evaluating the information that is given to them as part of the formal information policy (informed consent), in particular regarding the risks and discomfort to which they would agree to be exposed
About this study
Official title: An Open, Uncontrolled Trial in Healthy Volunteers to Explore the Plasma and Urinary Pharmacokinetics of a Single Oral Dose of 1,800 mg Red Vine Leaf Extract (Antistax®)
To describe the plasma and urinary pharmacokinetics of quercetin glucuronide and kaempferol glucuronide after the administration of a single peroral dose of 1,800mg Red Vine Leaf Extract (Antistax®). Additionally, the trial evaluated the safety and tolerability of this dose in healthy subjects.
- Conditions
- Healthy
- Being tested
- Red Vine Leaf Extract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red Vine Leaf ExtractDrug
| Study group | Role | What they receive |
|---|---|---|
| Red Vine Leaf Extract | Experimental | Not described Receives: Drug: Red Vine Leaf Extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum concentration of the analyte (Cmax)
Measured: up to 24 hours after drug administration
area under the curve (AUC) extrapolated to infinity (AUC0-inf)
Measured: up to 24 hours after drug administration
Secondary outcomes (5)
time to Cmax (Tmax)
Measured: up to 24 hours after drug administration
AUC under the time course of the quantifiable concentrations (AUC0-tz)
Measured: up to 24 hours after drug administration
apparent terminal disposition rate constant (λz)
Measured: up to 24 hours after drug administration
apparent terminal half-life (t1/2)
Measured: up to 24 hours after drug administration
Mean residence time (MRT)
Measured: up to 24 hours after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study startAug 2001
- Primary completionSep 2004
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.
- More trials run by Boehringer IngelheimThe 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02191241
- Sponsor's protocol ID
- 1138.9
- Status last verified
- Aug 2018
- First submitted
- 15 Jul 2014
- Last updated
- 31 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Uncontrolled Trial in Healthy Volunteers to Explore the Plasma and Urinary Pharmacokinetics of a Single Oral Dose of 1,800 mg Red Vine Leaf Extract (Antistax®)
- ClinicalTrials.gov ID
- NCT02191241
- Acronym / sponsor ID
- 1138.9
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Aug 2001
- Primary completion
- Sep 2004 (actual)
- First posted
- 16 Jul 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.
To describe the plasma and urinary pharmacokinetics of quercetin glucuronide and kaempferol glucuronide after the administration of a single peroral dose of 1,800mg Red Vine Leaf Extract (Antistax®). Additionally, the trial evaluated the safety and tolerability of this dose in healthy subjects.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Red Vine Leaf Extract | Experimental | Drug: Red Vine Leaf Extract |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- male or female (if female: either of non-childbearing potential or taking adequate contraceptive measures)
- caucasian
- age: 18 to 40 years old
- body mass index (BMI): 18-28 kg x m-2
- subjects who - on the basis of extensive pre-trial investigation - could be considered to be healthy
Key exclusion criteria (16 listed)
- if female: positive pregnancy test upon recruitment
- subjects with any relevant clinical abnormality (as based on extensive medical history, physical examination, vital signs)
- subjects with chronic or relevant acute infections
- subjects with therapy-requiring allergies (including drug allergies)
- subjects with suspicion of hypersensitivity to the investigational medication
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 |
|---|---|---|
| Red Vine Leaf Extract | Drug | Red Vine Leaf Extract |
Primary outcome
maximum concentration of the analyte (Cmax)
Time frame: up to 24 hours after drug administration
area under the curve (AUC) extrapolated to infinity (AUC0-inf)
Time frame: up to 24 hours after drug administration
5 secondary outcomes
time to Cmax (Tmax)
Time frame: up to 24 hours after drug administration
AUC under the time course of the quantifiable concentrations (AUC0-tz)
Time frame: up to 24 hours after drug administration
apparent terminal disposition rate constant (λz)
Time frame: up to 24 hours after drug administration
apparent terminal half-life (t1/2)
Time frame: up to 24 hours after drug administration
Mean residence time (MRT)
Time frame: up to 24 hours after drug administration
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 Aug 2018.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Red Vine Leaf Extract in people with Healthy, run by Boehringer Ingelheim.
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 16 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 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
maximum concentration of the analyte (Cmax) (time frame: up to 24 hours after drug administration). 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 31 Aug 2018.