None listed
Conditions
Interventions
Intervention1: α-DHTBZ 5 mg powder: Route of Administration Oral Dose Single Dose
Duration 01 day
Intervention2: α-DHTBZ 10 mg powder: Route of Administration Oral
Dose Single Dose
Duration 01 Day
I
Sponsors
Adeptio Pharmaceutical Limited
Eligibility
Inclusion criteria
Inclusion criteria: Healthy adult human (Male and/or non-pregnant, non-lactating female) subjects aged between 18 and 65 years (inclusive). Female of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test performed within 21 days prior to initiation of the study. Female subject must have a negative urine pregnancy test prior to check-in of each cohort. They must be using an acceptable form of contraception. For female of childbearing potential, acceptable forms of contraception include the following: i.Non hormonal intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study cohort, or ii.Hormonal contraception i.e. combined (estrogen and progestogen or progestogen only), or iii.Barrier methods containing or used in conjunction with a spermicidal agent, or iv.Surgical sterilization or v.Practicing sexual abstinence throughout the course of the study. Female will not be considered of childbearing potential if one of the following is reported and documented on the medical history: Postmenopausal with spontaneous amenorrhea for at least one year, or Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or Total hysterectomy and an absence of bleeding for at least 3 months. Healthy, non-smoking male human subjects aged between 18 and 65 years (inclusive). Subjects with a BMI between 18.5 â??30 kg/m2 and body weight not less than 50 kg. Subjects in normal health as determined by personal medical history, clinical examination including vital signs and clinically acceptable results of laboratory examinations (including serological tests). Subjects having a normal or clinically not significant 12-lead electrocardiogram (ECG) recording. Subjects having a normal or clinically not significant chest X-Ray (P/A view) (If taken during screening). A negative urine screen result for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine). A negative alcohol breath test result. Subjects willing to adhere to the protocol requirements and to provide written informed consent. Subjects who can provide adequate evidence of their identity. Availability of volunteer for the entire study duration. Ability to fast and consume standard meals.
Exclusion criteria
Exclusion criteria: Currently taking tetrabenazine, have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors (e.g. tetrabenazine). Currently taking VMat2 inhibitors e.g. valbenazine, deutetrabenazine. Hypersensitivity to heparin. Incapable of understanding the informed consent information. History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder. History or presence of mania. History or presence of suicide-related events and/or suicidal ideation. History or presence of epilepsy, schizophrenia and stroke. History or presence of a hypokinetic-rigid-syndrome (Parkinsonism). History or presence of depression. History or presence of pheochromocytoma. History or presence of pituitary tumours. Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within one month of starting the study. Subjects with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency. History or presence of alcoholism or drug abuse. History or presence of asthma, urticaria or other allergic reactions. History or presence of gastric and/or duodenal ulceration. History or presence of thyroid disease, adrenal dysfunction, organic intracranial lesion. Poor metabolisers i.e. CYP2D6. Use of reserpine. History or presence of cancer. Difficulty with donating blood. Difficulty in swallowing solids like tablets or capsules. • Difficulty in swallowing liquid like solution or suspension. • Difficulty in swallowing apple juice. • Use of any prescribed medication or any herbal medication during the two weeks before the start of the study or OTC medicinal products during the week prior to study initiation. • Use of monoamine oxidase inhibitors (MAOIs) and/or reserpine during the two weeks before the start of the study. • Subject chewed tobacco / consumed pan or pan masala, gutkha, masala (containing beetle nut and tobacco), xanthine-containing foods or beverages and grapefruit juice for 48.00 hours prior to initiation of the study. • Major illness during the 90 days before screening. • Participation in a drug research study within 90 days of screening. • Donation of blood within 90 days of screening. • Positive screening test result for any one or more of the following: HIV, Hepatitis B, Hepatitis C and VDRL. • History or presence of easy bruising or bleeding. • Abnormal diet patterns (for any reason) during the four weeks preceding the study, including fasting, high protein diets etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess bioavailability of (+)-α-DHTBZ from (+)-α-DHTBZ 5 mg, 10 mg, 15 mg and 22.5 mg powder of Adeptio Pharmaceuticals Limited, UK (Test product 1: 5mg powder, Test product 2: 10mg powder, Test product 3: 15 mg, Test product 4: 22.5 mg) in healthy, adult, human subjects under fasting conditions. To evaluate food effect of (+)-α-DHTBZ 15 mg of Adeptio Pharmaceuticals Limited, UK (Test product 3) under fasting and fed conditions. To assess multidose bioavailability and dose escalation of (+)-α-DHTBZ from (+)-α-DHTBZ 7.5 mg (twice daily) and 15 mg (once daily) powder of Adeptio Pharmaceuticals Limited, UK (Test product 5: 7.5 mg powder, Test product 3: 15 mg powder) in healthy, adult, human subjects under fasting conditions. Timepoint: Blood samples will be collected from each subject in each cohort at pre-dose and till 24.00 hr post dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| To establish maximum therapeutic dose To monitor the safety and tolerabilityTimepoint: Twenty-four post dose in each cohort. | — |
Countries
India
Contacts
Public ContactDr Prashant Mohite
Synapse Labs Pvt. Ltd.
Outcome results
None listed