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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-002979-40-NL
Enrollment
Unknown
Registered
2006-06-15
Start date
2006-08-07
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy volunteers

Interventions

Trade Name: Ketanest Product Name: Ketanest Product Code: ?? Pharmaceutical Form: Intravenous infusion INN or Proposed INN: S(+)ketamine CAS Number: 6740881 Current Sponsor code: KET Other descriptive

Sponsors

LUMC
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Healthy volunteers, 18+ years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Main Objective: To study the relationship with plasma concentrations of S+-ketamine and analgesia;Secondary Objective: ;Primary end point(s): 1) To obtain pharmacokinetic parameters of S(+)-ketamine; 2) To study the pharmacodynamic effects of intravenous S(+)-ketamine on experimental pain; 3) To study the pharmacodynamic effects of intravenous S(+)-ketamine using Bowdle scales.—

Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026