NCT04708795

Brief Summary

This study aims to investigate the uptake of AP701, a preparation from cannabis flowers, into the bloodstream after in single administration in healthy volunteers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 11, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2020

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 14, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2021

Completed
Last Updated

March 10, 2021

Status Verified

March 1, 2021

Enrollment Period

1.2 years

First QC Date

December 21, 2020

Last Update Submit

March 9, 2021

Conditions

PharmacokineticTolerabilitySafety

Keywords

CannabisCannabis based medicineTHCTetrahydrocannbinol

Outcome Measures

Primary Outcomes (3)

  • Evaluation of pharmacokinetic parameter of THC (area under the curve)

    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)

    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)

    Pharmacokinetic outcome of THC measured 0 to 30 hours after application of investigational product

    30 hours

Secondary Outcomes (15)

  • Evaluation of pharmacokinetic parameter of THC (area under the curve from timepoint zero to quantification limits)

    30 hours

  • Evaluation of pharmacokinetic parameter of THC (area under the curve from 0 to 24 hours)

    24 hours

  • Evaluation of pharmacokinetic parameter of THC (last drug concentration above quantification limits)

    30 hours

  • Evaluation of pharmacokinetic parameter of THC (time of last drug concentration above quantification limits)

    30 hours

  • Evaluation of pharmacokinetic parameter of THC (half-life associated with the terminal slope)

    30 hours

  • +10 more secondary outcomes

Study Arms (1)

Verum

EXPERIMENTAL

AP701 single dose oromucosal application

Drug: AP701

Interventions

AP701DRUG

Preparation of Cannabis flowers (Cannabis flos)

Verum

Eligibility Criteria

Age35 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Medical history of hypersensitivity or intolerance to the investigational product or its ingredients or to ingredients of similar chemical structure
  • Use of Cannabis products within the last 8 weeks
  • Use of opioids
  • Former or present dependency (e.g. to alcohol, medicinal products, drugs)
  • Present, former, or family history of mental illnesses such as severe de pression, psychosis, bipolar disorder, mania, obsessive compulsive disorder, and anxiety disorder
  • Acute severe somatic disease (e.g. gastrointestinal diseases, influenza)
  • Body temperature ≥ 38 °C
  • Present cardiovascular, respiratory, diabetic, or cancer disease
  • Hepatitis or other liver and renal disease
  • 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
  • Indications that the participant is unlikely to comply with the study protocol (e.g. lack of cooperation)
  • Taking any pharmaceutical products (including any medication interacting with metabolism of THC, e.g. St. John's wort)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Phase I Unit of CannaXan GmbH

Warngau, Bavaria, D-83627, Germany

Location

MeSH Terms

Conditions

Marijuana Abuse

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Stefan Lorenzl, PhD

    Phase I Unit of CannaXan GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2020

First Posted

January 14, 2021

Study Start

January 11, 2020

Primary Completion

March 7, 2021

Study Completion

March 7, 2021

Last Updated

March 10, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)