Phase 1
N=6
Absorption, Metabolism and Excretion Study of [14C]PBT2 and Absolute Bioavailability of PBT2
Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT02249728 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Absolute Bioavailability of PBT2 (F%) — 15.936 percentage of absolute bioavailability
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- IV PBT2 microtracer and oral PBT2 single dose (Drug); oral 14C-PBT2 (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- Male
- Sponsor
- Prana Biotechnology Limited
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Bioavailability of PBT2 (F%) |
15.936 | — |
| PRIMARY Mass Balance |
98.65 | — |
| SECONDARY IV PK Profile of [14C]-PBT2 and Total Radioactivity as Assessed by AUC(0 Last) |
3.40 | — |
| SECONDARY Oral PK Profile of PBT2 as Assessed by AUC(0-last) |
1330 | — |
| SECONDARY Safety and Tolerability of PBT2 |
1 | — |
| SECONDARY Ratio of Whole Blood, Plasma [14C] PBT2 at 24 Hours |
0.488 | — |
| SECONDARY Oral PK Profile of [14C]-PBT2 as Assessed by AUC(0-last) |
1660 | — |
Summary
The purpose of the study is to investigate how the test drug, PBT2, is taken up, broken down and removed from the body when given as an oral capsule, a radiolabelled oral suspension and a radiolabelled intravenous injection.
Eligibility Criteria
Inclusion Criteria
- Healthy males
- Body mass index of 18.0 to 35.0 kg/m2
Exclusion Criteria
- History of any drug or alcohol abuse in the past 2 years
- Regular alcohol consumption >21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
- Current smokers and those who have smoked within the last 12 months
- Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years.
- Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator
- Positive drugs of abuse test result
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
- History of cardiovascular, renal, hepatic, chronic respiratory or GI disease as judged by the investigator
Data sourced from ClinicalTrials.gov (NCT02249728). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.