Healthy
Conditions
Brief summary
The purpose of this study is to investigate the safety and tolerability of 3 multiple and escalating dose regimens of CG400549 administered orally in healthy volunteers.
Detailed description
This is a Phase 1, 3 cohorts study consisting of a randomised, double-blind, and placebo-controlled design.
Interventions
DRUGCG400549 640mg
multiple oral doses of 640 mg CG400549 (n=6) BID for 5 days (Days 1-5) and a final dose on Day 6 in the fed state
DRUGCG400549 320 mg
multiple oral doses of 320 mg CG400549 (n=6) QD for 5 days in the fed state
DRUGCG400549 640 mg
multiple oral doses of 640 mg CG400549 (n=6) QD for 5 days in the fed state
DRUGCG400549 960 mg
multiple oral doses of 960 mg CG400549 (n=6) QD for 5 days in the fed state
DRUGPlacebo 640mg
multiple oral doses of 640 mg placebo (n=2) BID for 5 days (Days 1-5) and a final dose on Day 6 in the fed state
DRUGPlacebo 320mg
multiple oral doses of 320 mg placebo (n=2) QD for 5 days in the fed state
DRUGplacebo 960 mg
multiple oral doses of 960 mg placebo (n=2) QD for 5 days in the fed state
Sponsors
CrystalGenomics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Age:18-55 years, inclusive * Body Mass Index :19-30 kg/m2, inclusive * Sex:male * Other criteria:healthy; non-smoking or smoking ≤ 10 cigarettes/day
Exclusion criteria
* Evidence of clinically relevant pathology * History of bacterial or viral infection requiring treatment with antibiotics or antivirals within 1 month of study * Presence or history of esophageal or gastroduodenal ulceration within 1 month before screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events | From Time the ICF is signed until Follow up Visit (15 days after study drug administration) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics-tmax(h), Cmax (ng/mL), Auc (0-24), T1/2(h) | Day1 and Day5 | To determine the pharmacokinetics of CG400549 following oral administration of multiple ascending doses of CG400549 in healthy male subjects. |
Countries
Netherlands
Outcome results
None listed