Clinical Trial on Pharmacokinetic and Tolerability of AP701

March 9, 2021 updated by: CannaXan GmbH
This study aims to investigate the uptake of AP701, a preparation from cannabis flowers, into the bloodstream after in single administration in healthy volunteers.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Pharmacokinetic parameters and tolerability of AP701 is studied over 30 hours after single dose administration in healthy volunteers in a prospective and open-label manner at a single study center.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Warngau, Bavaria, Germany, D-83627
        • Phase I Unit of CannaXan GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Signed and dated informed consent form
  2. Male in the age of 35 - 60 year at study start
  3. Body mass index of 18 to 30 kg/m2
  4. Non-smoker, no use of any Tabaco products
  5. Good general health status (Karnofsky Score = 100)
  6. Current ECG without abnormal findings (i.a. QTcF < 450 ms)
  7. Physical examination, medical history without exclusionary findings
  8. Pulse rate between 50 and 90 bpm
  9. Blood pressure between systolic 90 - 140 mmHg, diastolic 50 - 90 mmHg
  10. Lab values for liver function (ALT, AST, AP, Bilirubin total) within normal ranges
  11. Lab values for renal function (S-Creatinine, eGFR) within normal range
  12. Negative test result on HIV I, HIV II, hepatitis B cell surface antigen, hepatitis C antibody
  13. Negative test result of urine screening for Cannabis, alcohol, and substance abuse

Exclusion Criteria:

  1. Medical history of hypersensitivity or intolerance to the investigational product or its ingredients or to ingredients of similar chemical structure
  2. Use of Cannabis products within the last 8 weeks
  3. Use of opioids
  4. Former or present dependency (e.g. to alcohol, medicinal products, drugs)
  5. Participation in another clinical trial within the last four weeks prior to study inclusion
  6. Present, former, or family history of mental illnesses such as severe de pression, psychosis, bipolar disorder, mania, obsessive compulsive disorder, and anxiety disorder
  7. Acute severe somatic disease (e.g. gastrointestinal diseases, influenza)
  8. Body temperature ≥ 38 °C
  9. Present cardiovascular, respiratory, diabetic, or cancer disease
  10. Hepatitis or other liver and renal disease
  11. Other diseases or conditions that do not allow the participant to assess the nature and scope, and possible consequences of participating in this clinical trial
  12. Indications that the participant is unlikely to comply with the study protocol (e.g. lack of cooperation)
  13. Taking any pharmaceutical products (including any medication interacting with metabolism of THC, e.g. St. John's wort)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Verum
AP701 single dose oromucosal application
Drug: AP701
Preparation of Cannabis flowers (Cannabis flos)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evaluation of pharmacokinetic parameter of THC (area under the curve)
Time Frame: 30 hours
Pharmacokinetic outcome of THC measured 0 to 30 hours after application of investigational product
30 hours
Evaluation of pharmacokinetic parameter of THC (maximum observed drug concentration)
Time Frame: 30 hours
Pharmacokinetic outcome of THC measured 0 to 30 hours after application of investigational product
30 hours
Evaluation of pharmacokinetic parameter of THC (time to reach maximum drug concentration)
Time Frame: 30 hours
Pharmacokinetic outcome of THC measured 0 to 30 hours after application of investigational product
30 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluation of pharmacokinetic parameter of THC (area under the curve from timepoint zero to quantification limits)
Time Frame: 30 hours
Pharmacokinetic outcome of THC measured 0 to detection limits after application of investigational product
30 hours
Evaluation of pharmacokinetic parameter of THC (area under the curve from 0 to 24 hours)
Time Frame: 24 hours
Pharmacokinetic outcome of THC measured 0 to 24 hours after application of investigational product
24 hours
Evaluation of pharmacokinetic parameter of THC (last drug concentration above quantification limits)
Time Frame: 30 hours
Pharmacokinetic outcome of THC measured 0 to 30 hours after application of investigational product
30 hours
Evaluation of pharmacokinetic parameter of THC (time of last drug concentration above quantification limits)
Time Frame: 30 hours
Pharmacokinetic outcome of THC measured 0 to 30 hours after application of investigational product
30 hours
Evaluation of pharmacokinetic parameter of THC (half-life associated with the terminal slope)
Time Frame: 30 hours
Pharmacokinetic outcome of THC measured 0 to 30 hours after application of investigational product
30 hours
Evaluation of pharmacokinetic parameter of 11-OH-THC (area under the curve)
Time Frame: 30 hours
Pharmacokinetic outcome of 11-OH-THC measured 0 to 30 hours after application of investigational product
30 hours
Evaluation of pharmacokinetic parameter of 11-OH-THC (maximum observed drug concentration)
Time Frame: 30 hours
Pharmacokinetic outcome of 11-OH-THC measured 0 to 30 hours after application of investigational product
30 hours
Evaluation of pharmacokinetic parameter of 11-OH-THC (time to reach maximum drug concentration)
Time Frame: 30 hours
Pharmacokinetic outcome of 11-OH-THC measured 0 to 30 hours after application of investigational product
30 hours
Evaluation of pharmacokinetic parameter of 11-OH-THC (area under the curve from timepoint zero to quantification limits)
Time Frame: 30 hours
Pharmacokinetic outcome of 11-OH-THC measured 0 to 30 hours after application of investigational product
30 hours
Evaluation of pharmacokinetic parameter of 11-OH-THC (area under the curve from 0 to 24 hours)
Time Frame: 24 hours
Pharmacokinetic outcome of 11-OH-THC measured 0 to 24 hours after application of investigational product
24 hours
Evaluation of pharmacokinetic parameter of 11-OH-THC (last drug concentration above quantification limits)
Time Frame: 30 hours
Pharmacokinetic outcome of 11-OH-THC measured 0 to 30 hours after application of investigational product
30 hours
Evaluation of pharmacokinetic parameter of 11-OH-THC (time of last drug concentration above quantification limits)
Time Frame: 30 hours
Pharmacokinetic outcome of 11-OH-THC measured 0 to 30 hours after application of investigational product
30 hours
Evaluation of pharmacokinetic parameter of 11-OH-THC (half-life associated with the terminal slope)
Time Frame: 30 hours
Pharmacokinetic outcome of 11-OH-THC measured 0 to 30 hours after application of investigational product
30 hours
Adverse events (AE)
Time Frame: 30 hours
Number and severity of adverse events (AE)
30 hours
Pschotropic drug effects measured by questionnaire
Time Frame: 30 hours
Questionnaire comprising 17 questions on intoxication to be answered on numeric rating scale
30 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CannaXan GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stefan Lorenzl, PhD, Phase I Unit of CannaXan GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 11, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 7, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 7, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 21, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 10, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SELECT (Other Identifier: Folktandvården Stockholms län AB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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