None listed
Conditions
Brief summary
This study is a first-in-man clinical study of DLP-114, a Risperidone Para-aminobenzoate Implant product. The study is an open-label, single sequence design aimed at assessing the safety and tolerability of DLP-114 and evaluating its utility in achieving a PK profile that is comparable to the marketed oral form of risperidone. Healthy volunteers will be enrolled implanted with DLP-114 in groups of up to 3 volunteers per group. The first group of 3 healthy volunteers to receive the DLP-114 implant will be a sentinel group. The safety and tolerability of the DLP-114 implant will be assessed in the sentinel group for at least 28 days prior to any other volunteers being dosed implanted with DLP-114 in the study. Only if the safety and tolerability data, obtained from the sentinel group, are considered acceptable by the investigator and the sponsor, will the remainder of healthy volunteers commence implant treatment in the study. Treatment of each subject will be conducted in five sequential periods: 1. Oral risperidone (2 mg/day) – tolerability assessment; 2. Oral risperidone (1 mg/day) – PK assessment; 3. Washout; 4. DLP-114 implant treatment; 5. Follow-up.
Interventions
The study duration for each subject involved in the study will be up to 202 days. This includes the following:
• Screening period (28 days)
• Oral risperidone (2 mg/day) – tolerability assessment (3 days);
• Oral risperidone (1 mg/day) – PK assessment (11 days);
• Washout (not less than 1 day, not more than 30 days);
• DLP-114 implant treatment (123 days);
• Follow-up (7 Days).
The study durg DLP-114 is a Risperidone Para-aminobenzoate Implant that is a combination drug-device product designed
The study duration for each subject involved in the study will be up to 202 days. This includes the following: • Screening period (28 days) • Oral risperidone (2 mg/day) – tolerability assessment (3 days); • Oral risperidone (1 mg/day) – PK assessment (11 days); • Washout (not less than 1 day, not more than 30 days); • DLP-114 implant treatment (123 days); • Follow-up (7 Days). The study durg DLP-114 is a Risperidone Para-aminobenzoate Implant that is a combination drug-device product designed to continuously elute the equivalent of a daily 1 mg oral dose of risperidone following subcutaneous implantation. The DLP-114 device will be implanted in the medial aspect of the upper arm halfway between the elbow and the shoulder, in line with the crease between the biceps and triceps muscles, using a sterile disposable implanter tool and local anesthesia in a minimally invasive procedure identical to that of other approved drug device products. The device will remain implanted for 123 days. Upon completion of the implant treatment period, the device will be removed by a qualified medical officer.
Sponsors
Delpor Australia Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy adult male and non-pregnant females
Exclusion criteria
1. Known hypersensitivity to titanium, implant materials or procedure; 2. Known hypersensitivity or allergy to lidocaine or any local anesthetic agent of the amide type (local anesthetic used during implant and explant procedures); 3. History of abnormal scar formation or family history of keloid formation; 4. Disorders of the central nervous system, including psychiatric disorders, behavioral disturbances, cerebrovascular events, depression, bipolar disorder, migraine, Parkinson’s disease. 5. History of treatment for marked depression, anxiety, tension, or agitation; currently on medication for asthma; use of any MAOI within 14 days prior to dosing; history of surgery requiring anesthesia within 8 weeks prior to start of dosing; 6. Blood or plasma donation within 30 days prior to start of dosing. All subjects will be advised not to donate blood or plasma for six weeks after completing the study.
Outcome results
None listed