Table 1 Summary of the study designs, population demographics (mean ± SD), and analysis methods of in-house data available from studies CHDR1311 and CHDR1016 on (S)-(nor)ketamine

From: Predictive performance of parent-metabolite population pharmacokinetic models of (S)-ketamine in healthy volunteers

  CHDR1311 CHDR1016
Study design
Administered drug (S)-ketamine (S)-ketamine
Infusion dose and duration 10 mg in 30 min Pre-amendment (N = 4)*
t = 0: 0.04 mg/kg (bolus)
t = 0-6 min: 0.7 mg/kg/h (females +5%)
t = 7-29 min: 0.45 mg/kg/h (females +10%)
t = 30-120 min: 0.3 mg/kg/h (females +15%)
Post-amendment (N = 27)*
t = 0: 0.026 mg/kg (bolus)
t = 0-14 min: 0.425 mg/kg/h (females +5%)
t = 15-39 min: 0.275 mg/kg/h (females +10%)
t = 40-120 min: 0.15 mg/kg/h (females +15%)
PK-sampling schedule (h) 0.5 - 1 - 2 - 3 - 4 - 5 - 6 - 7 - 8 - 9 - 10 0.5 - 1 - 1.5 - 2 -2.5 - 4.5 - 5.0 - 5.5
Sampling methodology Venous Venous
Analysis method LC–MS/MS HPLC-UV
LLOQ (ng/mL) (S)-ketamine: 1.00 ng/mL
(S)-norketamine: 0.50 ng/mL
10 ng/mL
Samples (n) (BLQ) 268 (0%) 864 (5.9%)
Demographics
Population Healthy volunteers Healthy volunteers
N (male) 17 (9) 31 (17)
Age (year) 23.0 ± 3.6 23.6 ± 5.1
BMI 21.6 ± 2.0 22.4 ± 2.0
Weight (kg) 68.0 ± 7.2 71.3 ± 8.5
Registration
Clinical trial number (EudraCT) 2013-003443-28 2010-022203-21
Approval by Ethics Committee (CCMO) NL46000.058.13 NL33486.058.10
  1. LC-MS/MS liquid chromatography–mass spectrometry, HPLC-UV high-performance liquid chromatography with ultraviolet detection, LLOQ lower limit of quantification, BLQ below limit of quantification, CCMO Central Committee on Research Involving Human Subjects
  2. *CHDR1016 consisted of two occasions, the high (S)-ketamine concentration infusion was double the amount of the low (S)-ketamine concentration infusion, which is shown here