Irinotecan PK ± medicinal cannabis CSV JSON

In Vivo Interaction Study

Irinotecan PK ± medicinal cannabis

No Effect (based on bioequivalence limits) was detected.

irinotecan

medicinal cannabis

  • CYP3A

Table 2

Results

Table 2.

Sample Compound measured Measurement Value Study sequence Additional information N replicates

Experimental Conditions

Parallel

Population

Females
Males
Patients

No marijuana use

12

M = 7, F = 5
Age 58 (27-66)
All with metastatic cancer "for which irinotecan or docetaxel was considered an adequate option, which was refractory to conventional treatment or for which there was no standard regimen."
Please refer to Table 1 in the text for further information

Pharmacokinetic (PK) Sampling Information

Immediate prior infusion, 30 min before end of infusion (EOI); at 10, 20, 30 min, 1, 1.5, 2, 3, 4, 5, 6, 22.5, 30, 46.5, and 54 hr after EOI

Drug or Natural Product Administration

Object Administration — irinotecan

Intravenous

Injection (250 mL NSS)

600 mg for first treatment, 450 mg or as per previous response

QW

90-min infusion, 1 week

Precipitant Administration — medicinal cannabis

Oral

Solution

18% THC, 0.8% CBD (200 mL, 1 g/L)

QPM

15 days starting day 10 of first treatment

Natural Product Characteristics

Office for Medicinal Cannabis, The Hague, The Netherlands

Herbal tea

Not specified

Pharmacodynamics (PD) & Adverse Events

Hepatobiliary disorders 35900000
Immune system disorders 36000000

Varying degrees of reduction of WBC and neutrophil count. Please refer to Table 4 for further information.

Hepatobiliary disorders 35900000
Immune system disorders 36000000

Varying degrees of reduction of WBC and neutrophil count. Please refer to Table 4 for further information.