Cannabidiol Bioavailability Trial With Oral Multiple Dose Administration

NCT04790136 | Completed Phase 1

• 2 other identifiers: 1393cbd20ct2020-004807-15
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Glatt Pharmaceutical Services GmbH \& Co. KG is developing a new CBD granules formulation (GLA-015 / Cannabidiol 1500 mg 29,7% w/w GRA BLD P) which is intended to be used in the treatment of the new Coronavirus disease 2019 (COVID-19). Due to its enhanced solubility the new product is expected to show increased bioavailability, reduced variability especially in the fasted state and better robustness towards food interaction compared to oil-based cannabidiol solutions. The aim of the present clinical trial is the characterisation of maximum systemic exposure of CBD and its active metabolite 7-OH-CBD of the newly developed Test product in the estimated target effective dose for treatment of COVID-19 as well as the comparison of its systemic bioavailability to CBD administered as oily solution. Comparison of maximum systemic exposure of Test vs. Reference will be performed under steady state conditions with twice daily intake after a light meal over 7 consecutive days.

Conditions

Comparative Bioavailability

Keywords

Bioavailability; Cannabidiol

Outcome Measures

Primary Outcomes (6)

• Comparison of relative bioavailability of Test vs. Reference after multiple dose administration after a light meal determined by use of AUC144-168,ss of cannabidiol

  AUC144-168,ss = partial area under the concentration vs. time curve over both dosing intervals on PK profiling day (i.e. starting with the morning dose on study day 7 to 12 h after the evening dose on study day 7), calculated by means of the linear up/log down method (linear trapezoidal rule for increases in concentration/logarithmic trapezoidal rule for decreases in concentrations)

  24 hours

• Comparison of relative bioavailability of Test vs. Reference after multiple dose administration after a light meal determined by use of Cmax,144-168,ss of cannabidiol

  Cmax,144-168,ss = observed maximum concentration over both dosing intervals on PK profiling day (i.e. starting with the morning dose on study day 7 to 12 h after the evening dose on study day 7), considering scheduled times

  24 hours

• Comparison of relative bioavailability of Test vs. Reference after multiple dose administration after a light meal determined by use of Cmin,144-168,ss of cannabidiol

  Cmin,144-168,ss = (absolute) minimum concentrations over both dosing intervals on PK profiling day (i.e. starting with the morning dose on study day 7 to 12 h after the evening dose on study day 7), considering scheduled times

  24 hours

• Comparison of relative bioavailability of Test vs. Reference after multiple dose administration after a light meal determined by use of AUC144-168,ss of 7-OH-CBD

  AUC144-168,ss = partial area under the concentration vs. time curve over both dosing intervals on PK profiling day (i.e. starting with the morning dose on study day 7 to 12 h after the evening dose on study day 7), calculated by means of the linear up/log down method (linear trapezoidal rule for increases in concentration/logarithmic trapezoidal rule for decreases in concentrations)

  24 hours

• Comparison of relative bioavailability of Test vs. Reference after multiple dose administration after a light meal determined by use of Cmax,144-168,ss, of 7-OH-CBD

  Cmax,144-168,ss = observed maximum concentration over both dosing intervals on PK profiling day (i.e. starting with the morning dose on study day 7 to 12 h after the evening dose on study day 7), considering scheduled times

  24 hours

• Comparison of relative bioavailability of Test vs. Reference after multiple dose administration after a light meal determined by use of Cmin,144-168,ss of 7-OH-CBD

  Cmin,144-168,ss = (absolute) minimum concentrations over both dosing intervals on PK profiling day (i.e. starting with the morning dose on study day 7 to 12 h after the evening dose on study day 7), considering scheduled times

  24 hours

Secondary Outcomes (2)

• Frequency of Adverse Events

  14 days

• Frequency of subjects showing Adverse Events

  14 days

Study Arms (2)

GLA-015

EXPERIMENTAL

GLA-015 (Glatt Pharmaceutical Services GmbH \& Co. KG, Germany); 5.051 g granules containing 1500 mg cannabidiol to be dispersed in water; oral multiple dose administration twice daily over 7 consecutive days after a light meal

Drug: GLA-015

DAC C-052 "Cannabidiol" / NRF 22.10 "Oily cannabidiol solution 100 mg/ml"

ACTIVE COMPARATOR

DAC C-052 "Cannabidiol" / NRF 22.10 "Ölige Cannabidiol-Lösung 100 mg/ml" ("Oily cannabidiol solution 100 mg/ml") (Glatt Pharmaceutical Services GmbH \& Co. KG, Germany; according to DAC/NRF specifications); 15 ml solution containing 1500 mg cannabidiol; oral multiple dose administration twice daily over 7 consecutive days after a light meal

Drug: DAC C-052 "Cannabidiol" / NRF 22.10 "Oily cannabidiol solution 100 mg/ml"

Interventions

GLA-015 DRUG

administration followed by PK blood sampling

GLA-015

DAC C-052 "Cannabidiol" / NRF 22.10 "Oily cannabidiol solution 100 mg/ml" DRUG

administration followed by PK blood sampling

DAC C-052 "Cannabidiol" / NRF 22.10 "Oily cannabidiol solution 100 mg/ml"

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ethnic origin: Caucasian
• age: 18 years or older (including)
• body-mass index (BMI): \>= 18.5 kg/m² and \<= 30.0 kg/m²
• good state of health
• non-smoker or ex-smoker for at least 1 month
• written informed consent, after having been informed about benefits and potential risks of the clinical trial, as well as details of the insurance taken out to cover the subjects participating in the clinical trial

You may not qualify if:

• Safety concerns
• existing cardiac and/or haematological diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient
• existing hepatic and/or renal diseases or pathological findings, which might interfere with the safety or tolerability, and/or pharmacokinetics of the active ingredient
• existing gastrointestinal diseases or pathological findings, which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of the active ingredient
• history of relevant CNS and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders
• hepatic impairment
• history of bradycardia, tachycardia or other arrhythmic symptoms of clinical significance
• Nurses Global Assessment of Suicide Risk (NGASR)-scale showing a high or very high risk
• known allergic reactions to the active ingredients used or to constituents of the pharmaceutical preparations
• history of severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical trial by the investigator
• systolic blood pressure \< 90 or \> 139 mmHg
• diastolic blood pressure \< 60 or \> 89 mmHg
• heart rate \< 50 bpm or \> 90 bpm
• QTc interval \> 450 ms for men and \> 470 ms for women
• ASAT \> 20% ULN, ALAT \> 10% ULN, bilirubin \> 20% ULN (except in case of existing Morbus Gilbert-Meulengracht deduced from anamnesis/medical history) and creatinine \> 0.1 mg/dL ULN (limit of \> 0.1 mg/dL correspondents to of \> 9 µmol/l ULN)

Sponsors & Collaborators

• SocraTec R&D GmbH: lead
• Glatt Pharmaceutical Services GmbH & Co. KG: collaborator
• SocraMetrics GmbH: collaborator

Study Sites (1)

SocraTec R&D GmbH Clinical Pharmacology Unit

Erfurt, Thuringia, 99084, Germany

Location

Study Officials

• Frank Donath

  SocraTec R&D GmbH Clinical Pharmacology Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 10, 2021
• Study Start: March 17, 2021
• Primary Completion: April 16, 2021
• Study Completion: May 12, 2021
• Last Updated: July 13, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)