A randomized, placebo-controlled study of the safety and tolerability of PTG-100 in healthy volunteers

A randomized, double-blind, placebo-controlled study of single and multiple ascending doses of PTG-100 in normal healthy volunteers.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615001201561

Enrollment

Registered

2015-11-05

Start date

2015-12-17

Completion date

2016-05-23

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The study is to assess the safety and tolerability of PTG-100 to normal healthy volunteers. This includes vital signs, safety labs and physical examinations The drug will be given in single ascending then multiple ascending doses. The study will also evaluate the PK of the drug after dose administration. Participants will be entered into standard study cohorts

Interventions

Oral administration Starting dose 100mg, then 300mg and 1000mg. Single (=1 day) and multiple (=14 days) for each dose of PTG-100 Each dose tested in a new cohort

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

Male

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

Normal healthy volunteers 18-55 years Good general health BMI 18-30kg/m2 Lab values within normal range Ability and willingness to attend visits to the site

Exclusion criteria

History of significant abnormalities or diseases Clinical significant lab or ECG abnormalities Mentally or legally incapacitated History of substance abuse Inability to comply with the requirements of the study protocol

Outcome results