Status:
COMPLETED
CG-549 Tablet Pharmacokinetics Study
Lead Sponsor:
CrystalGenomics, Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This will be an open label, crossover, single dose study consisting of 2 parts (Part A and Part B) in a total of 24 healthy male and female subjects.
Detailed Description
Part A Part A is an open-label, 3-period, fixed-sequence, escalating dose study in 6 healthy subjects to find a tablet dose that results in a CG-549 exposure that is expected to be safe and potentiall...
Eligibility Criteria
Inclusion
- Key
- Sex:Males and females
- Age:18 to 55 years, inclusive, at screening
- Weight:≥50 kg, at screening
- Body mass index:18.0 to 30.0 kg/m2, inclusive, at screening
- Smoking behavior :Non-smoking or smoking ≤5 cigarettes, 1 cigar, or 1 pipe per day
- Other criteria:Liver enzymes within the normal range and creatine phosphokinase within 2.0 times the normal range
- Key
Exclusion
- Previous participation in the current study.
- Employee of PRA or the Sponsor.
- History of bacterial or viral infection requiring treatment with antibiotics or antivirals within 1 month prior to screening.
- Presence or history of esophageal or gastroduodenal ulceration within 1 month prior to screening.
- Significant and/or acute illness within 5 days prior to the first drug administration that may impact safety assessments, in the opinion of the Investigator.
Key Trial Info
Start Date :
September 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2020
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05393856
Start Date
September 23 2019
End Date
June 30 2020
Last Update
May 26 2022
Active Locations (1)
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1
PRA Health Sciences (PRA) - Early Development Services (EDS)
Groningen, Netherlands