A Study of Different Oral Thin Film (S)-Ketamine Formulations for Sublingual Administration in Healthy Participants

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: OTF 3; Drug: OTF 2; Drug: OTF 4; Drug: OTF 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT04300621

CR108774

2019-004428-39 (EudraCT Number)

54135419EDI1003 (Other Identifier)

Details and patient eligibility

About

The purpose of the study in healthy participants is to characterize the plasma pharmacokinetic (PK) profile of different single dose Oral Thin Film (OTF) (S)-ketamine formulations administered sublingually.

Enrollment: 16 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body Mass Index (BMI) between 20.0 and 28.0 kilogram per square meters (kg/m^2) inclusive (BMI=weight/height^2) with a minimum weight of 60 kilogram (kg) and a maximum of 100 kg
• 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

• Cardiac arrhythmias or other cardiac disease, hematological disease, hypertension, lipid abnormalities, respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, Parkinson's disease, infection, glaucoma, epilepsy or any other illness that the Investigator considers should exclude the participant
• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

16 participants in 4 patient groups

Treatment Sequence 1: OTF 1, 4, 2, 3

Experimental group

Description:

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.

Treatment:

Drug: OTF 1

Drug: OTF 4

Drug: OTF 2

Drug: OTF 3

Treatment Sequence 2: OTF 2, 1, 3, 4

Experimental group

Description:

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.

Treatment:

Drug: OTF 1

Drug: OTF 4

Drug: OTF 2

Drug: OTF 3

Treatment Sequence 3: OTF 3, 2, 4, 1

Experimental group

Description:

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.

Treatment:

Drug: OTF 1

Drug: OTF 4

Drug: OTF 2

Drug: OTF 3

Treatment Sequence 4: OTF 4, 3, 1, 2

Experimental group

Description:

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.

Treatment:

Drug: OTF 1

Drug: OTF 4

Drug: OTF 2

Drug: OTF 3