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

NCT02249728 | Completed Phase 1 Results

• 2 other identifiers: PBT2-1022014-000389-24
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• Absolute Bioavailability of PBT2 (F%)

  Absolute bioavailability is the amount of drug from a formulation that reaches the systemic circulation relative to an IV dose, computed as AUC(oral)/AUC(IV), with range from 0% (no drug) to 100% (all of the administered drug).

  0 to 72 hours post oral dose

• Mass Balance

  Amount excreted as a percentage of the administered dose (%Ae)

  168 h (7 days) post dose

Secondary Outcomes (5)

• IV PK Profile of [14C]-PBT2 and Total Radioactivity as Assessed by AUC(0 Last)

  0 to 72 h post oral dose

• Oral PK Profile of PBT2 as Assessed by AUC(0-last)

  72 h post oral dose

• Safety and Tolerability of PBT2

  72 h post oral dose

• Ratio of Whole Blood, Plasma [14C] PBT2 at 24 Hours

  0 to 24 hours

• Oral PK Profile of [14C]-PBT2 as Assessed by AUC(0-last)

  0 to 72 hours

Study Arms (2)

Absolute Bioavailability

EXPERIMENTAL

IV PBT2 microtracer and oral PBT2 single dose

Drug: IV PBT2 microtracer and oral PBT2 single dose

Radiolabelled AME

EXPERIMENTAL

oral 14C PBT2

Drug: oral 14C-PBT2

Interventions

IV PBT2 microtracer and oral PBT2 single dose DRUG

Absolute Bioavailability

oral 14C-PBT2 DRUG

Radiolabelled AME

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy males
• Body mass index of 18.0 to 35.0 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Prana Biotechnology Limited: lead

Study Sites (1)

Quotient Clinical

Nottingham, Nottinghamshire, NG11 6JS, United Kingdom

Location

Results Point of Contact

• Title: Dr Dianne Angus
• Organization: Prana Biotechnology

info@pranabio.com

+61 393494906

Study Officials

• Caroline Herd, PhD

  Prana Biotechnology Ltd

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2014
• First Posted: September 26, 2014
• Study Start: June 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: March 30, 2016
• Results First Posted: March 30, 2016

Record last verified: 2016-02

Locations

GB (1)