Absorption, Metabolism and Excretion Study of [14C]PBT2 and Absolute Bioavailability of PBT2

Healthy Volunteers Clinical Trial

Official title:

A Phase I , Open-Label Study to Evaluate the Absorption, Metabolism and Excretion of [14C]-PBT2 and to Estimate the Absolute Bioavailability of PBT2 in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02249728
• Other study ID #: PBT2-102
• Secondary ID: 2014-000389-24
• Status: Completed
• Phase: Phase 1
• First received: July 30, 2014
• Last updated: September 25, 2014
• Start date: June 2014
• Est. completion date: July 2014

Study information

• Verified date: September 2014
• Source: Prana Biotechnology Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• IV PBT2 microtracer and oral PBT2 single dose

• oral 14C-PBT2

Locations

Country	Name	City	State
United Kingdom	Quotient Clinical	Nottingham	Nottinghamshire

Sponsors (1)

Lead Sponsor	Collaborator
Prana Biotechnology Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute bioavailability of PBT2 (F)		72 hours post oral dose	No
Primary	Mass balance recovery of total radioactivity in urine, faeces, and urine and faeces combined: amount excreted (Ae) and Ae as a percentage of the administered dose (%Ae)		168 h (7 days) post dose	No
Secondary	IV PK profile of [14C]-PBT2 and total radioactivity (Tmax, Cmax, AUC(0 last), AUC(0 inf), AUC%extrap, lambda z, T1/2el, CL, Vd, Vss and MRT)		72 h post oral dose	No
Secondary	Oral PK profile of PBT2 (Tlag, Tmax, Cmax, AUC(0-last), AUC(0-inf), AUC%extrap, lambda-z, T1/2el and MRT)		72 h post oral dose	No
Secondary	Safety and tolerability of PBT2 (number of participants with adverse events)		72 h post oral dose	Yes
Secondary	Distribution of total radioactivity into blood cells (whole blood:plasma ratios)		Up to 168 hours	No
Secondary	Oral PK profile of [14C]-PBT2 (Tlag, Tmax, Cmax, AUC(0-last), AUC(0-inf), AUC%extrap, lambda-z, T1/2el and MRT)		72 hours	No