A Study of Different Oral Thin Film (S)-Ketamine Formulations for Sublingual Administration in Healthy Participants
NCT ID: NCT04300621
Last Updated: 2025-04-27
Study Results
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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COMPLETED
PHASE1
16 participants
INTERVENTIONAL
2020-06-19
2020-08-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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Treatment Sequence 1: OTF 1, 4, 2, 3
Participants will receive a single dose of (S)-ketamine administered sublingually through OTF 1 in period 1; followed by OTF 4 in period 2; followed by OTF 2 in period 3; followed by OTF 3 in period 4, on Day 1 of each treatment period under fasted conditions. A washout period of at least 72 hours will be maintained between each treatment period.
OTF 1
Participants will receive (S)-ketamine administered sublingually through OTF 1.
OTF 2
Participants will receive (S)-ketamine administered sublingually through OTF 2.
OTF 3
Participants will receive (S)-ketamine administered sublingually through OTF 3.
OTF 4
Participants will receive (S)-ketamine administered sublingually through OTF 4.
Treatment Sequence 2: OTF 2, 1, 3, 4
Participants will receive a single dose of (S)-ketamine administered sublingually through OTF 2 in period 1; followed by OTF 1 in period 2; followed by OTF 3 in period 3; followed by OTF 4 in period 4, on Day 1 of each treatment period under fasted conditions. A washout period of at least 72 hours will be maintained between each treatment period.
OTF 1
Participants will receive (S)-ketamine administered sublingually through OTF 1.
OTF 2
Participants will receive (S)-ketamine administered sublingually through OTF 2.
OTF 3
Participants will receive (S)-ketamine administered sublingually through OTF 3.
OTF 4
Participants will receive (S)-ketamine administered sublingually through OTF 4.
Treatment Sequence 3: OTF 3, 2, 4, 1
Participants will receive a single dose of (S)-ketamine administered sublingually through OTF 3 in period 1; followed by OTF 2 in period 2; followed by OTF 4 in period 3; followed by OTF 1 in period 4, on Day 1 of each treatment period under fasted conditions. A washout period of at least 72 hours will be maintained between each treatment period.
OTF 1
Participants will receive (S)-ketamine administered sublingually through OTF 1.
OTF 2
Participants will receive (S)-ketamine administered sublingually through OTF 2.
OTF 3
Participants will receive (S)-ketamine administered sublingually through OTF 3.
OTF 4
Participants will receive (S)-ketamine administered sublingually through OTF 4.
Treatment Sequence 4: OTF 4, 3, 1, 2
Participants will receive a single dose of (S)-ketamine administered sublingually through OTF 4 in period 1; followed by OTF 3 in period 2; followed by OTF 1 in period 3; followed by OTF 2 in period 4, on Day 1 of each treatment period under fasted conditions. A washout period of at least 72 hours will be maintained between each treatment period.
OTF 1
Participants will receive (S)-ketamine administered sublingually through OTF 1.
OTF 2
Participants will receive (S)-ketamine administered sublingually through OTF 2.
OTF 3
Participants will receive (S)-ketamine administered sublingually through OTF 3.
OTF 4
Participants will receive (S)-ketamine administered sublingually through OTF 4.
Interventions
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OTF 1
Participants will receive (S)-ketamine administered sublingually through OTF 1.
OTF 2
Participants will receive (S)-ketamine administered sublingually through OTF 2.
OTF 3
Participants will receive (S)-ketamine administered sublingually through OTF 3.
OTF 4
Participants will receive (S)-ketamine administered sublingually through OTF 4.
Eligibility Criteria
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Inclusion Criteria
* Participant must be healthy based on clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology or urinalysis are outside the normal reference ranges, retesting of an abnormal lab value(s) that may lead to exclusion will be allowed once during the screening phase
* Nonsmoker (not smoked for 3 months prior to screening)
* A woman must have a negative serum beta-human chorionic gonadotropin (beta-hCG) at screening and a negative urine pregnancy test on Day -1 of each Period
* A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 1 month after the last study intervention administration
Exclusion Criteria
* Positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies or human immunodeficiency virus (HIV) antibodies at screening visit
* Drinks, on average, more than 5 cups of tea/coffee/cocoa or 8 cans of cola per day
* Clinically significant acute illness within 7 days prior to each study intervention administration
* History of clinically significant drug and/or food allergies including known allergies, hypersensitivity, or intolerance to JNJ-54135419 or its excipients
18 Years
50 Years
ALL
Yes
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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SGS Life Science Services
Antwerp, , Belgium
Countries
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Other Identifiers
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2019-004428-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
54135419EDI1003
Identifier Type: OTHER
Identifier Source: secondary_id
CR108774
Identifier Type: -
Identifier Source: org_study_id
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