Clinical TrialHealthy VolunteersKetaminePlaceboCompleted

Pharmacokinetic-pharmacodynamic modeling of S(+)-ketamine in healthy volunteers

Randomised, single-blind, placebo-controlled crossover study (n=12) assessing IV S(+)-ketamine PK/PD and experimental analgesia in healthy volunteers.

Target Enrollment
12 participants
Study Type
interventional
Design
Randomized, single Blind

Detailed Description

S(+)-ketamine (Ketanest) intravenous infusion is studied to characterise pharmacokinetics and pharmacodynamics and to develop a PK/PD model predicting concentration and analgesic effect.

Primary aims are to obtain PK parameters of S(+)-ketamine and to assess its effects on experimental pain using electrical and heat pain models; outcomes include plasma concentration, analgesia, EEG, ECG and blood pressure.

Design: placebo-controlled, single-blind, randomised crossover with short IV infusions (≤100 minutes), arterial/venous sampling and standard safety monitoring; ondansetron available for nausea.

Study Protocol

Preparation

sessions

Dosing

2 sessions
100 min each

Integration

sessions

Study Arms & Interventions

S(+)-ketamine

experimental

IV S(+)-ketamine infusion (Ketanest)

Interventions

  • Ketamine
    via IV• single dose• 1 doses total

    IV infusion up to 100 minutes (Ketanest) for PK/PD and experimental pain testing.

Placebo

inactive

Saline intravenous infusion (placebo)

Interventions

  • Placebo
    via IV• single dose• 1 doses total

    Saline placebo infusion matched to active.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Healthy volunteers.

Exclusion Criteria

  • Obesity (BMI > 30).
  • Presence of medical disease (heart, lung, liver, kidney, neurologic disease; diabetes mellitus; pyrosis; diaphragmatic hernia).
  • Presence of psychiatric disease.
  • History of chronic alcohol or drug use.
  • Allergy to study medications.
  • Possibility of pregnancy.
  • Lactation.

Study Details

  • Status
    Completed
  • Type
    interventional
  • Design
    Randomizedsingle Blind
  • Target Enrollment12 participants
  • Timeline
    Start: 2007-09-10
    End: 2010-01-01
  • Compounds
    KetaminePlacebo
  • Topic
    Healthy Volunteers

Locations

Netherlands

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