HealthyPhase 18265134NCT01638442
Crossover Trial of the Effect of a High-Fat Meal on the PK of Oral CHR 2797 in Healthy Male Subjects
A Phase 1 study testing CHR-2797 in people with Healthy, run by CTI BioPharma at 1 site in United States.
Trial summary
The objectives of this study are to evaluate the safety and tolerability; and to determine the effect of food on the pharmacokinetics (PK) of CHR-2797 in normal healthy male subjects. 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?
- CHR-2797
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Sep 2012
- 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
- Male subjects between 18 and 55 years of age, inclusive.
- Within BMI range of 18.5 to 29.9 kg/m2, inclusive.
- In good health, determined by no clinically significant ongoing diseases or other conditions that require medication, and/or any other findings from medical history, physical examination, 12-lead ECG, and vital signs.
- Clinical laboratory evaluations (including chemistry panel fasted [fasted approximately 10 hours], CBC, and UA) within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator.
- Negative test for selected drugs of abuse at Screening (does not include alcohol) and at Check-in (does include alcohol; Appendix A).
- Negative hepatitis panel (including hepatitis B surface antigen [HBsAg] and hepatitis C virus [anti-HCV], and negative HIV antibody screens (Appendix A);
- Males will either be sterile or agree to use 1 of the following approved methods of contraception: a male condom with spermicide; a sterile sexual partner; use by female sexual partner of an intrauterine device with spermicide; a female condom with spermicide; contraceptive sponge with spermicide; an intravaginal system (e.g., NuvaRing®), a diaphragm with spermicide; a cervical cap with spermicide; or oral, implantable, transdermal, or injectable contraceptives from Check-in (Day -1 of Period 1) until 90 days following Clinic Discharge (Day 10).
- Able to comprehend and willing to sign an Informed Consent Form (ICF).
Who cannot join
- Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder (as determined by the Investigator).
- Have a disease or condition that requires daily medication.
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator.
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (except that appendectomy, hernia repair, and/or cholecystectomy will be allowed).
- History or presence of an abnormal ECG, which, in the Investigator's opinion, is clinically significant.
- History of alcoholism or drug addiction within 1 year prior to Check-in (Day -1 of Period 1).
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- Use of any tobacco- or nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to Check-in (Day -1 of Period 1).
- Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 30 days prior to Check-in (Day -1 of Period 1).
- Use of any prescription medications/products within 14 days prior to Check-in (Day 1 of Period 1), unless deemed acceptable by the Investigator;
- Use of any over-the-counter (OTC), non-prescription preparations (including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations) within 7 days prior to Check-in (Day -1 of Period 1), unless deemed acceptable by the Investigator.
- Use of alcohol-, grapefruit-, or caffeine-containing foods or beverages within 72 hours prior to Check-in (Day -1 of Period 1), unless deemed acceptable by the Investigator.
- Poor peripheral venous access.
- Donation of blood from 30 days prior to Screening through Study Completion, inclusive, or of plasma from 2 weeks prior to Screening through Study Completion, inclusive.
- Receipt of blood products within 2 months prior to Check-in (Day -1 of Period 1).
- Any acute or chronic condition that, in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in this clinical study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit Inc.
Evansville, Indiana, 47710
About this study
Official title: An Open-label, Randomized, Two-way Crossover Trial of the Effect of a High-Fat Meal on the Pharmacokinetics of Oral Tosedostat (CHR 2797) in Healthy Male Subjects
The objectives of this study are to evaluate the safety and tolerability; and to determine the effect of food on the pharmacokinetics (PK) of CHR-2797 in normal healthy male subjects.
Read the detailed description
This will be a single center, open-label, 2-arm, 2-way, crossover trial to assess the effect of food on CHR-2797 PK following a single 120 mg dose. Approximately 18 normal, healthy male subjects will be enrolled with at least 12 subjects completing the study. Two 60 mg capsules will be administered for a 120 mg dose of CHR-2797 on Days 1 and 8 with a high-fat meal or in the fasted state according to the randomization schedule. Subjects will be confined at the clinical research unit (CRU) from the time of Period 1 Check-in until Clinic Discharge on Day 3, and will return to the CRU on Day 7 for Period 2 Check-in and remain in the CRU until Study Completion (on Day 10 of Period 2). Blood samples for PK analysis will be collected through 48 hours post dose.
- Conditions
- Healthy
- Being tested
- CHR-2797
- Keywords
- Male subjects, healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHR-2797Drug
Two 60 mg capsules (120 mg dose) of CHR-2797 administered orally with 240 mL room temperature tap water after an approximately 10 hour fast.
CHR-2797Drug
Two 60 mg capsules (120 mg dose) of CHR-2792 administered orally with 240 mL room temperature tap water within 30 minutes of receiving a high-fat meal.
--------------------------------------------------------------------------------
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Two 60 mg capsules (120 mg dose) of CHR-2797 administered orally with 240 mL room temperature tap water after an approximately 10 hour fast. Receives: Drug: CHR-2797 |
| Treatment B | Experimental | Two 60 mg capsules (120 mg dose) of CHR-2792 administered orally with 240 mL room temperature tap water within 30 minutes of receiving a high-fat meal. Receives: Drug: CHR-2797 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Outcome Measurement
Report adverse events, vital signs, electrocardiograms, and clinical laboratory test.
Averse events, clinical labs, and other safety variables will be analyzed descriptively for all sujects who recieve at least 1 dose of study drug.
Measured: 10 days
Pharmacokinetic Parameter
For each subject the following PK parameters will be calculated, whevever possible, based on the plasma concentrations of CHR-2797 and its metabolite CHR-79888:
- Maximum observed concentration (Cmax)
- time to maximum concentration (t-max)
- area under the concentration-time curve from Hour 0 to the last measureable concentration (AUC0-t)
- apparent terminal elimination rate constant
- apparent terminal elimination half-life
Measured: 10 days
Secondary outcomes (1)
Adverse Events
Adverse events will be summarized by presenting the number and percentages of subjects having any adverse event by MED DRA system organ class and preferred term, relationship to study drug and severity/CTCAE grade. All adverse events will be listed.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionJul 2012
- Study completionSep 2012
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- CTI BioPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chroma Therapeutics
- Responsible party
- Sponsor
- Investigators
- Randall Stoltz, MD, Principal investigator, CovanceSimran Singh, MS, GWCPM, Study chair, CTI BioPharmaBob Wright, PM, Study director, CovanceJack Singer, MD, Study director, CTI BioPharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01638442
- Sponsor's protocol ID
- TST101
- Acronym
- 8265134
- Status last verified
- Sep 2023
- First submitted
- 18 Jun 2012
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Two-way Crossover Trial of the Effect of a High-Fat Meal on the Pharmacokinetics of Oral Tosedostat (CHR 2797) in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01638442
- Acronym / sponsor ID
- 8265134 / TST101
- Conditions
- Healthy
- Keywords
- Male subjects, healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- CTI BioPharmaIndustry (pharma, biotech, devices)
- Collaborators
- Chroma Therapeutics
- Study start
- Jun 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 11 Jul 2012 (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.
The objectives of this study are to evaluate the safety and tolerability; and to determine the effect of food on the pharmacokinetics (PK) of CHR-2797 in normal healthy male subjects.
Detailed description
This will be a single center, open-label, 2-arm, 2-way, crossover trial to assess the effect of food on CHR-2797 PK following a single 120 mg dose. Approximately 18 normal, healthy male subjects will be enrolled with at least 12 subjects completing the study. Two 60 mg capsules will be administered for a 120 mg dose of CHR-2797 on Days 1 and 8 with a high-fat meal or in the fasted state according to the randomization schedule. Subjects will be confined at the clinical research unit (CRU) from the time of Period 1 Check-in until Clinic Discharge on Day 3, and will return to the CRU on Day 7 for Period 2 Check-in and remain in the CRU until Study Completion (on Day 10 of Period 2). Blood samples for PK analysis will be collected through 48 hours post dose.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: CHR-2797Two 60 mg capsules (120 mg dose) of CHR-2797 administered orally with 240 mL room temperature tap water after an approximately 10 hour fast. |
| Treatment B | Experimental | Drug: CHR-2797Two 60 mg capsules (120 mg dose) of CHR-2792 administered orally with 240 mL room temperature tap water within 30 minutes of receiving a high-fat meal. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male subjects between 18 and 55 years of age, inclusive.
- Within BMI range of 18.5 to 29.9 kg/m2, inclusive.
- In good health, determined by no clinically significant ongoing diseases or other conditions that require medication, and/or any other findings from medical history, physical examination, 12-lead ECG, and vital signs.
- Clinical laboratory evaluations (including chemistry panel fasted [fasted approximately 10 hours], CBC, and UA) within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator.
- Negative test for selected drugs of abuse at Screening (does not include alcohol) and at Check-in (does include alcohol; Appendix A).
Key exclusion criteria (15 listed)
- Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder (as determined by the Investigator).
- Have a disease or condition that requires daily medication.
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator.
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (except that appendectomy, hernia repair, and/or cholecystectomy will be allowed).
- History or presence of an abnormal ECG, which, in the Investigator's opinion, is clinically significant.
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 |
|---|---|---|
| CHR-2797Two 60 mg capsules (120 mg dose) of CHR-2797 administered orally with 240 mL room temperature tap water after an approximately 10 hour fast. | Drug | Treatment A |
| CHR-2797Two 60 mg capsules (120 mg dose) of CHR-2792 administered orally with 240 mL room temperature tap water within 30 minutes of receiving a high-fat meal. -------------------------------------------------------------------------------- | Drug | Treatment B |
Primary outcome
Safety Outcome Measurement
Time frame: 10 days
Report adverse events, vital signs, electrocardiograms, and clinical laboratory test. Averse events, clinical labs, and other safety variables will be analyzed descriptively for all sujects who recieve at least 1 dose of study drug.
Pharmacokinetic Parameter
Time frame: 10 days
For each subject the following PK parameters will be calculated, whevever possible, based on the plasma concentrations of CHR-2797 and its metabolite CHR-79888: * Maximum observed concentration (Cmax) * time to maximum concentration (t-max) * area under the concentration-time curve from Hour 0 to the last measureable concentration (AUC0-t) * apparent terminal elimination rate constant * apparent terminal elimination half-life
1 secondary outcome
Adverse Events
Time frame: 10 days
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 18 Sep 2023.
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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.
Randall Stoltz, MD principal investigator
Covance
Simran Singh, MS, GWCPM study chair
CTI BioPharma
Bob Wright, PM study director
Covance
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 CHR-2797 in people with Healthy, run by CTI BioPharma at 1 site in United States.
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 8 inclusion and 15 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 18 Sep 2023. 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 United States. 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. 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?
Safety Outcome Measurement (time frame: 10 days). The study lists 2 primary outcomes in all. 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 18 Sep 2023.