Phase 1
Completed N=6
Absorption, Metabolism and Excretion Study of [14C]PBT2 and Absolute Bioavailability of PBT2
Healthy Volunteers
Source: ClinicalTrials.gov NCT02249728 ↗
Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcomePrimary: Absolute Bioavailability of PBT2 (F%) — 15.936 percentage of absolute bioavailability
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.
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 | — |
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. Informational only — not medical advice.