HealthyPhase 1NCT01085578
CG400549 Single Ascending Dose Study
A Phase 1 study testing CG400549 in people with Healthy, run by CrystalGenomics, Inc. at 1 site in Netherlands.
Trial summary
Evaluation of Safety, Tolerability and Pharmacokinetic Characteristics of CG400549 in Healthy Volunteers Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CG400549
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2009to Dec 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Safety,Tolerability and Pharmacokinetic Characteristics of CG400549 in Healthy Volunteers
Evaluation of Safety, Tolerability and Pharmacokinetic Characteristics of CG400549 in Healthy Volunteers
Read the 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.
- Conditions
- Healthy
- Being tested
- CG400549/placebo, CG400549
- Keywords
- healthy male volunteers, fasted and fed state
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CG400549/placeboDrug
Also called Cohort 1
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
CG400549/placeboDrug
Also called Cohort 2
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
CG400549Drug
Also called Cohort 3
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
| Study group | Role | What they receive |
|---|---|---|
| Cohort1 | Placebo comparator | CG400549/placebo Receives: Drug: CG400549/placebo |
| Cohort2 | Placebo comparator | CG400549/placebo Receives: Drug: CG400549/placebo |
| Cohort3 | Other | CG400549 Receives: Drug: CG400549 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Participants Who Experienced Serious or Non-Serious Adverse Events
Measured: up to 4 weeks
Secondary outcomes (2)
Maximum Observed Plasma Concentration of CG400549 (Cmax)
Measured: 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)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2010 (estimated)
- Study startOct 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- CrystalGenomics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Seonggu Ro, PhD, Study chair, CrystalGenomics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01085578
- Sponsor's protocol ID
- CG400549-1-01
- Status last verified
- May 2022
- First submitted
- 10 Mar 2010
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety,Tolerability and Pharmacokinetic Characteristics of CG400549 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01085578
- Acronym / sponsor ID
- CG400549-1-01
- Conditions
- Healthy
- Keywords
- healthy male volunteers, fasted and fed state
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- CrystalGenomics, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 12 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of Safety, Tolerability and Pharmacokinetic Characteristics of CG400549 in Healthy Volunteers
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort1 | Placebo comparator | Drug: CG400549/placeboCG400549/placebo |
| Cohort2 | Placebo comparator | Drug: CG400549/placeboCG400549/placebo |
| Cohort3 | Other | Drug: CG400549CG400549 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CG400549/placeboAlso: Cohort 1Period 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 | Drug | Cohort1 |
| CG400549/placeboAlso: Cohort 2Period 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 | Drug | Cohort2 |
| CG400549Also: Cohort 3Period 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 | Drug | Cohort3 |
Primary outcome
The Number of Participants Who Experienced Serious or Non-Serious Adverse Events
Time frame: up to 4 weeks
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seonggu Ro, PhD study chair
CrystalGenomics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CG400549 in people with Healthy, run by CrystalGenomics, Inc. at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number of Participants Who Experienced Serious or Non-Serious Adverse Events (time frame: up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2022.