Randomized, Double-Blind, Double-Dummy, Placebo-Controlled 4-way Crossover Study to assess the Pharmacodynamics and Pharmacokinetics of Oral and Intravenous S-Ketamine in Healthy Volunteers

Completed

• Conditions: Depression; depressive disorder; 10027946

• Registration Number: NL-OMON55261
• Lead Sponsor: Centre for Human Drug Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 16

Inclusion Criteria

1. Healthy female or male subjects, 18 to 45 years of age, inclusive. Healthy
status is defined by absence of evidence of any active or chronic disease
following a detailed medical, surgical and psychiatric history, a complete
physical examination including vital signs, 12-lead electrocardiogram (ECG),
haematology, blood chemistry, and urinalysis.
2. Able to participate and willing to give written informed consent and to
comply with the study restrictions.
3. Use of any form of birth control is required for heterosexual subjects of
childbearing potential who are sexually active during the study, either used by
the subject or their sexual partner.
4. Able to read and understand English at a sufficient level in order to
participate in the ETB.

Exclusion Criteria

1. Positive test for drugs of abuse at screening or pre-dose.
2. The subject has a positive pregnancy test.
3. History (within 3 months of screening) of alcohol consumption exceeding 2
standard drinks per day on average.
4. History or symptoms of any significant disease including (but not limited
to), neurological, endocrine, cardiovascular, respiratory, gastrointestinal,
hepatic, or renal disorder.
5. The subject has a previous or current, or a family history of, a clinically
significant psychiatric disorder, including substance use disorder.
6. A history or family history of epilepsy, seizures or convulsions.
7. Having metal objects in brain or skull.
8. The subject has a history of intracranial mass lesion, hydrocephalus and/or
head injury or trauma.
8. Having a cochlear implant or implanted deep brain stimulator.
9. Abnormal sleeping pattern (e.g. working night shifts).
10. Resting motor threshold (rMT) of more than 75% of the maximum stimulator
output, measured using TMS-EMG during screening.
11. Systolic blood pressure (SBP) greater than 140 mmHg during screening. The
measurement may be repeated before randomization to confirm eligibility or
judged to be clinically irrelevant for healthy subjects.
12. Use of any medications within 14 days of study drug administration, or less
than 5 half-lives (whichever is longer).
13. Use of more than 5 cigarettes (or other tobacco or nicotine products with
equivalent nicotine dose) daily within the previous month before the first dose
administration, and/or unable or unwilling to not smoke during the in-house
periods.
15. Regular recreational use of illicit drugs (notably ketamine) within 12
months of screening.

Study & Design

• Study Type: Interventional
• Study Design: Not specified