A Phase 1 Bioavailability Study of Arbaclofen Placarbil M... | NCT03058237

ID	Type	Description	Link
2016-003792-22	EudraCT Number

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Part 1: Regimen A	Experimental	One low dose Arbaclofen Placarbil MR Prototype A tablet taken under fasting conditions. Part 1 participants receive Regimens A, B, C, D and E in a sequential manner.	Drug: Arbaclofen Placarbil MR Prototype A
Part 1: Regimen B	Experimental	One low dose Arbaclofen Placarbil MR Prototype B tablet taken under fasting conditions. Part 1 participants receive Regimens A, B, C, D and E in a sequential manner.	Drug: Arbaclofen Placarbil MR Prototype B
Part 1: Regimen C	Active Comparator	One low dose Arbaclofen Placarbil SR tablet taken under fasting conditions as the reference product. Part 1 participants receive Regimens A, B, C, D and E in a sequential manner.	Drug: Arbaclofen Placarbil SR
Part 1: Regimen D	Experimental	One low dose tablet of the selected Arbaclofen Placarbil MR Prototype administered with 0.6 g/kg of beverage in orange juice. Part 1 participants receive Regimens A, B, C, D and E in a sequential manner.	Drug: Arbaclofen Placarbil MR Prototype A Drug: Arbaclofen Placarbil MR Prototype B
Part 1: Regimen E	Experimental

Name	Type	Description	Arm Group Labels	Other Names
Arbaclofen Placarbil SR	Drug	One low dose oral tablet of Arbaclofen Placarbil sustained release (SR) in the fasted state.	Part 1: Regimen C

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Part 1: Time to Maximum Concentration (Tmax) of Arbaclofen Placarbil (AP) and R-baclofen in Low Dose Arbaclofen Placarbil Modified Release (MR) Prototypes A + B	Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in low dose arbaclofen placarbil modified release (MR) prototypes A and B.	Day 1 (pre-dose), post-dose up to 48 hours

Secondary Outcomes

Measure	Description	Time Frame
Part 1: Maximum Observed Concentration (Cmax) of Arbaclofen Placarbil (AP) and R-baclofen in Low Dose Arbaclofen Placarbil Modified Release (MR) Prototypes A + B	Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in low dose arbaclofen placarbil modified release (MR) prototypes A and B.	Day 1 (pre-dose), post-dose up to 48 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy males
Non-pregnant, non-lactating healthy females
Body mass index of 18.0 to 30.0 kg/m^2 or, if outside the range, considered not clinically significant by the investigator
Must be willing and able to communicate and participate in the whole study
Must provide written informed consent prior to any study-specific procedures
Must agree to use an adequate method of contraception

Exclusion Criteria:

Subjects who have received any IMP in a clinical research study within the previous 3 months
Subjects who are study site employees, or immediate family members of a study site or sponsor employee
Subjects who have previously been enrolled in this study
History of any clinically significant drug/substance or alcohol abuse or disorders in the past 2 years
Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
Regular alcohol consumption <5 units per week on average
Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening and each admission
Current smokers of e-cigarettes and nicotine replacement products and those who have smoked these products within the last 12 months
Females of childbearing potential who are pregnant or lactating (female subjects must have a negative urine pregnancy test). A woman is considered of childbearing potential unless she is permanently sterile (hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or is postmenopausal (had no menses for 12 months without an alternative medical cause and a serum follicle-stimulating hormone [FSH] concentration ≥40 IU/L)
Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening
Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator
Clinically significant abnormal ECG as judged by the investigator, including a QT interval corrected using Fridericia's formula of >450 msec in males and >470 msec in females
Positive drugs of abuse test result at screening and each admission (drugs of abuse tests are listed in the protocol)
Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance of <70 mL/min using the Cockcroft-Gault equation
History of cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease or psychiatric disorder, as judged by the investigator
History of surgical procedures involving the brain or meninges, encephalitis, meningitis, degenerative central nervous system disorder (eg, Alzheimer's or Parkinson's Disease), epilepsy, mental retardation, or any other disease/procedure/accident/intervention associated with significant injury to or malfunction of the central nervous system, or a history of significant head trauma within the past 2 years, or currently receiving anticonvulsant therapy for any reason
Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever is allowed unless it is active
Donation or loss of greater than 400 mL of blood within the previous 3 months
Subjects who are taking, or have taken, any prescribed or over-the-counter drug (other than 4 g per day paracetamol, hormone replacement therapy and hormonal contraceptives) or herbal remedies in the 14 days before IMP administration. Exceptions may apply on a case by case basis, if considered not to interfere with the objectives of the study, as agreed by the PI and sponsor's medical monitor.
Failure to satisfy the investigator of fitness to participate for any other reason