KetaMoHydBup: Pharmacokinetic Interaction of S-ketamine, Morphine, Hydromorphone and Buprenorphine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-31

Study Completion Date

2023-12-31

Brief Summary

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S-ketamine is often administered as a part of multimodal analgesia to reduce postoperative pain and postoperative opioid consumption. Current data indicates that ketamine may be useful for patients with prior use of opioids whereas the benefit for opioid-naive patients is less clear. However, different opioids have variable pharmacokinetic characteristics. Therefore, it is important to evaluate S-ketamine's effect on the pharmacokinetics of opioids.

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Detailed Description

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S-ketamine is often used as a part of multimodal analgesia to reduce postoperative pain and opioid consumption, in part by mitigating opioid tolerance and opioid-induced hyperalgesia. However, there are mixed results concerning the effect of ketamine for this indication. Different opioids have various pharmacokinetic characteristics. Ketamine is known to inhibit the liver UGT2B7-enzyme, that is responsible for e.g., morphine metabolism. Therefore, it is important to investigate whether there is a clinically important pharmacokinetic interaction between S-ketamine and opioids metabolized via liver UGT2B7 enzyme. These opioids include morphpine, hydromorphone and buprenoprhine.

Conditions

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The Effect of S-ketamine on Pharmacokinetics of Morphine, Hydromorphone, and Buprenorphine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This is a cross-over study with two phases on 12 healthy volunteers. Study participants will be administered S-ketamine 0.29mg/kg/h intravenously or placebo (NaCl 0.9%) for 4 hours. 30 minutes after the initiation of the study drug infusion, each subject will be given single boluses of morphine 0.01mg/kg, hydromorphone 0.002mg/kg and buprenorphine 0.003mg/kg IV. We will analyze pharmacokinetic parameters (Cmax, tmax, AUC, t1/2) for morphine, hydromorphone, and buprenorphine. The aim of the study is to evaluate whether S-ketamine has a pharmacokinetic interaction with the opioids (morphine, hydromorphone, buprenorphine) known to be metabolized via liver UGT2B7 enzyme.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

This is a double-blind study. Study participants, investigators, care providers and personnel collecting samples are blinded. Personnel preparing study drugs will not participate on conducting the study. On the first phase of the study, study participants will be administered one of the study drug infusions (either S-ketamine or placebo). The order of the study drug is random. On the second phase, study participants will be administered the other study drug (S- ketamine or placebo) that she/he did not receive on the first phase.

Study Groups

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S-ketamine infusion

12 healthy volunteers, S-ketamine infusion 0.29 mg/kg/h for 4 hours

Group Type EXPERIMENTAL

S-ketamine

Intervention Type DRUG

S-ketamine infusion 0.29 mg/kg/h for 4 hours

Placebo (NaCl 0.9%) infusion

12 healthy volunteers, placebo (NaCl 0.9%) infusion for 4 hours

Group Type PLACEBO_COMPARATOR

S-ketamine

Intervention Type DRUG

S-ketamine infusion 0.29 mg/kg/h for 4 hours

Interventions

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S-ketamine

S-ketamine infusion 0.29 mg/kg/h for 4 hours

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* written informed consent
* age 18-45 years
* healthy
* Normal values in the following laboratory assessments: Hb, P-ALAT, P-AFOS, P-GT, P-creatinine, P-K, P-Na, chemical sample for urine (U-KemSeul). Pregnancy test (P-hCG-tot) must be negative.
* Urine sample for detection of any illegal drugs must be negative (U-Huum-PS)
* Normal EKG
* Normal blood pressure
* No prior use of illicit drugs

Exclusion Criteria

* Tendency/predisposition to illicit drug use, illicit drug use in history
* Abnormal EKG
* smoking
* use of oral contraceptives
* pregnancy, lactation
* participating in a less tha 3 months ago
* Blood donation less than 3 months ago
* The subject's peripheral veins are hardly visible (predisposing difficulties in cannulation)
* weight less than 50 kg, body mass index (BMI) less than 18,5 or over 30

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes