Food Effects Study on the Pharmacokinetics of Oral BTD-001 (QCL117965)
Research type
Research Study
Full title
A Phase 1 Cross-over Study to Determine Food Effects on the Pharmacokinetics of Oral BTD-001 and Metabolites in Healthy Volunteers, Followed by an Optional Multiple Dose Study to Assess Pharmacokinetics of Oral BTD-001
IRAS ID
225768
Contact name
Patricia Walicke
Contact email
Sponsor organisation
Balance Therapeutics, Inc.
Eudract number
2017-001109-34
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 2 months, 5 days
Research summary
The Sponsor is developing the test medicine, BTD-001, also know as pentetrazol (PTZ), for the potential treatment of idiopathic hypersomnia (IH) and narcolepsy which are rare sleep disorders. IH is characterised by excessive sleepiness and narcolepsy causes a person to suddenly fall asleep.
This study aims to determine how much test medicine is taken up by the body when the test medicine is taken with food. The study may also look at how much test medicine is taken up by the body when given multiple times a day.
The study will consist of up to 2 parts. Part 1 will be dosed in 12 healthy male and female volunteers. Volunteers will receive two single doses of 100 mg BTD-001 on 2 separate occasions, one in the fasted state and one in the fed state. Volunteers will be resident in the clinical unit for 5 days after each dose and there will be a minimum of 14 days between each dose.
Part 2 is optional and the decision to proceed to the optional second part will be made following a review of Part 1 data. If carried out, it is planned that Part 2 will be dosed in 1 cohort of 8 volunteers who took part in Part 1. Volunteers will receive up to 400 mg for up to 8 days. The dose level, interval (once, twice or three times a day) and the duration of dosing may be amended following review of Part 1 data but will not exceed 400 mg per day for 8 days. The dose conditions (fed, fasted or on an empty stomach) will also be determined following Part 1 data review. Volunteers will be resident in the clinical unit for 11 days.
During clinical residency blood samples will be taken at regular intervals.
REC name
HSC REC A
REC reference
17/NI/0073
Date of REC Opinion
28 Apr 2017
REC opinion
Favourable Opinion