- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01085578
CG400549 Single Ascending Dose Study
May 16, 2022 updated by: CrystalGenomics, Inc.
Evaluation of Safety,Tolerability and Pharmacokinetic Characteristics of CG400549 in Healthy Volunteers
Evaluation of Safety, Tolerability and Pharmacokinetic Characteristics of CG400549 in Healthy Volunteers
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This was a Phase 1, 2-part study consisting of a randomized, double-blind, placebo-controlled,single ascending dose (SAD) part (in 2 alternating panels) and a 1-sequence food effect (FE) part.
In the SAD part, 2 cohorts of 6 healthy male subjects each received a single oral dose of CG400549 or placebo in 3 periods, randomized such that each subject received active treatment twice and placebo once (in each period, 4 subjects received active drug and 2 received placebo).
In the FE part, 1 cohort of 6 healthy male subjects received a single oral dose of CG400549 in the fasted state in Period 1 and a single oral dose of CG400549 in the fed state in Period 2.
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Zuidlaren, Netherlands
- PRA International clinical center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 1. Sex : male
- 2. Age : 18-55 years, inclusive
- 3. BMI : 19-30 kg/m2
- 4. Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, "powerdrinks"), grapefruit (juice) and tobacco products from 48 h prior to entry in the clinical research centre until discharge
- 5. Medical history without major pathology
- 6. Normal blood pressure (systolic 90-140 mmHg; diastolic 60-90 mmHg) and heart rate (45 90 beats per minute); minor deviations from these criteria could be accepted if considered to be clinically insignificant by the Medical Investigator
- 7. Computerised (12-lead) ECG recording normal or showing no clinically relevant deviations as judged by the Medical Investigator
- 8. Male subjects and their female sexual partners must use double-barrier contraception during the study period and for 90 days after follow-up
- 9. All values for haematology and for clinical chemistry tests of blood and urine within the normal range or showing no clinically relevant deviations as judged by the Medical Investigator. In particular, liver enzymes (aspartate aminotransferase [ASAT] and alanine aminotransferase [ALAT]) must be within the normal range and creatine phosphokinase (CPK) must be within 2.0 times the normal range.
- 10. Willingness to sign the written Informed Consent Form (ICF)
Exclusion Criteria:
- 1. Evidence of clinically relevant pathology
- 2. History of bacterial or viral infection requiring treatment with antibiotics or antivirals within 1 month of study
- 3. Presence or history of esophageal or gastroduodenal ulceration within 1 month before screening.
- 4. Family history of significant cardiac disease (e.g., sudden cardiac death or myocardial infarction prior to age 50 in a first-degree relative)
- 5. Mental handicap, relevant cognitive or psychiatric disorders or history of seizures
- 6. History and/or presence of relevant drug and/or food allergies
- 7. Use of concomitant medication, except for acetaminophen (paracetamol), which is allowed up to 3 days before entrance into the research facility. All other medication (including over-the-counter medication, health supplements, and herbal remedies such as St. John's Wort extract) must have been stopped at least 14 days prior to the first dose. The use of a limited amount of acetaminophen (≤ 2 g/day) is permitted.
- 8. Participation in a drug study within 60 days prior to drug administration. Participation in more than 3 other drug studies in the 10 months preceding the start of this study.
- 9. Donation of more than 50 mL of blood (whole blood or blood component) within 60 days prior to drug administration.
- 10. History of alcohol abuse or drug addiction (including soft drugs like cannabis products)
- 11. Positive screen on drugs of abuse (opiates, methadone, cocaine, amphetamines, cannabinoids), barbiturates, benzodiazepines, tricyclic antidepressants and alcohol
- 12. Intake of more than 24 units of alcohol per week (one unit of alcohol equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits)
- 13. Positive screen on hepatitis B surface antigen (HBsAg)
- 14. Positive screen on anti hepatitis C virus (HCV)
- 15. Positive screen on anti human immunodeficiency virus 1 and 2 (HIV 1/2)
- 16. Illness within 5 days prior to drug administration
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Cohort1
CG400549/placebo
|
Period 1: a single oral dose of 80 mg CG400549 or placebo on Day 1 Period 2: a single oral dose of 320 mg CG400549 or placebo on Day 1 Period 3: a single oral dose of 1280 mg CG400549 or placebo on Day 1
Other Names:
Period 1: a single oral dose of 160 mg CG400549 or placebo on Day 1 Period 2: a single oral dose of 640 mg CG400549 or placebo on Day 1 Period 3: a single oral dose of 1920 mg CG400549 or placebo on Day 1
Other Names:
|
Placebo Comparator: Cohort2
CG400549/placebo
|
Period 1: a single oral dose of 80 mg CG400549 or placebo on Day 1 Period 2: a single oral dose of 320 mg CG400549 or placebo on Day 1 Period 3: a single oral dose of 1280 mg CG400549 or placebo on Day 1
Other Names:
Period 1: a single oral dose of 160 mg CG400549 or placebo on Day 1 Period 2: a single oral dose of 640 mg CG400549 or placebo on Day 1 Period 3: a single oral dose of 1920 mg CG400549 or placebo on Day 1
Other Names:
|
Other: Cohort3
CG400549
|
Period 1: a single oral dose of 640 mg CG400549 on Day 1 in the fasted state Period 2: a single oral dose of 640 mg CG400549 on Day 1 in the fed state
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The Number of Participants Who Experienced Serious or Non-Serious Adverse Events
Time Frame: up to 4 weeks
|
up to 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum Observed Plasma Concentration of CG400549 (Cmax)
Time Frame: pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36 and 48 hour post-dose
|
pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36 and 48 hour post-dose
|
Area Under the Concentration-Time Curve of CG400549 (AUC)
Time Frame: pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36 and 48 hour post-dose
|
pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36 and 48 hour post-dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Seonggu Ro, PhD, CrystalGenomics, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
March 10, 2010
First Submitted That Met QC Criteria
March 11, 2010
First Posted (Estimate)
March 12, 2010
Study Record Updates
Last Update Posted (Actual)
May 20, 2022
Last Update Submitted That Met QC Criteria
May 16, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- CG400549-1-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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