HealthyPhase 1NCT01159808
A Study of the Safety and Pharmacokinetics of Single Ascending Oral Doses of INX-08189 in Healthy Subjects
A Phase 1 study testing INX-08189 in people with Healthy, run by Bristol-Myers Squibb.
Trial summary
The purpose of this study is to test the safety of different dose strengths of INX-08189 in healthy adults. The study will also look at how rapidly the drug breaks down in the body (pharmacokinetics or PK). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- INX-08189
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- May 2010to Oct 2010
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy men and post-menopausal (absence of periods for more than 2 years) surgically sterile, or non-pregnant, non-lactating women using a reliable form of contraception (see Inclusion Criteria 9)
- Age 18 to 65 years, inclusive
- Normal (no clinically significant abnormalities) laboratory tests (chemistry, hematology and urinalysis)
- No clinically significant abnormalities on ECG (QTcB interval must be < 450 ms)
- Weight ≥ 50kg and Body Mass Index (BMI) of 19 to 30, inclusive
- Negative urine drug screen at screening and on Study Day -1
Show all 11Show fewer
- Negative serum βHCG pregnancy test at screening and on Study Day -1 (for all women)
- Hepatitis B surface antigen, hepatitis C antibody, and HIV antibody negative
- Agreement to practice a barrier method of birth control plus the use of a spermicide throughout the study period by both male and female subjects (oral contraceptives are not permitted)
- Able to complete all study visits
- Signed informed consent form (ICF)
Who cannot join
- Any active medical problem for which the subject is being evaluated and/or treated
- Calculated creatinine clearance (calculated using the IDMS traceable equation for the MDRD value) < 50 mL/min/1.73 m2
- Regular use of medications, prescription or non-prescription; no medication may be taken within 1 week prior to study dosing
- Use of alcohol within 48 hours prior to dosing (subjects must also agree to not use alcohol for 96 hours after dosing)
- Current lactation or breastfeeding
- Major surgery within 30 days prior to dosing
Show all 9Show fewer
- Receipt of an investigational drug within 30 days prior to dosing
- Donation of blood or plasma within 30 days prior to dosing
- Any other problem, that in the opinion of the Investigator, will affect the safety of the subject or outcome of the study
About this study
The purpose of this study is to test the safety of different dose strengths of INX-08189 in healthy adults. The study will also look at how rapidly the drug breaks down in the body (pharmacokinetics or PK). The study objectives include:
- To evaluate the safety of single ascending oral doses of INX-08189 in healthy subjects
- To characterize the pharmacokinetic (PK) profile of single ascending oral doses of INX-08189 in healthy subjects
- To assess the food effect on the PK of a single oral dose of INX-08189
- Conditions
- Healthy
- Being tested
- INX-08189, Placebo
- Keywords
- Safety and Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INX-08189Drug
3, 25 and 100 mg capsules; oral administration, single dose
PlaceboDrug
matching placebo capsules, oral administration, single dose
| Study group | Role | What they receive |
|---|---|---|
| INX-08189 | Experimental | Not described Receives: Drug: INX-08189 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety of single ascending oral doses of INX-08189 in healthy subjects
Safety will be evaluated on the basis of adverse event (AE) incidence, changes in serum chemistry and hematology values, urinalysis results, and changes in vital signs and in electrocardiogram (ECG) findings.
Measured: periodically over 14 days
Characterize the pharmacokinetic (PK) profile of single ascending oral doses of INX-08189 in healthy subjects
Including a determination of maximum observed plasma concentration (Cmax), time at which the maximum plasma concentration was observed (Tmax), time at which concentrations are first measurable in the plasma (Tlag), area under the plasma concentration-time curve from time 0 to time of last measurable plasma concentration (AUC 0-last) and elimination half-life (T 1/2) after single ascending oral doses.
Measured: periodically over 14 days
Assess the effect of a high fat meal on the PK parameters
The effect of food (standard high-fat meal) on the absorption of INX-08189 will be evaluated
Measured: periodically over 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2010 (estimated)
- Study startMay 2010
- Primary completionAug 2010
- Study completionOct 2010
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.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian Boehlecke, MD, MSPH, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01159808
- Sponsor's protocol ID
- AI472-001
- Other IDs
- INH-189-001
- Status last verified
- Jun 2012
- First submitted
- 1 Jul 2010
- Last updated
- 22 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Safety and Pharmacokinetics of Single Ascending Oral Doses of INX-08189 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01159808
- Acronym / sponsor ID
- AI472-001
- Conditions
- Healthy
- Keywords
- Safety and Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 9 Jul 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.
The purpose of this study is to test the safety of different dose strengths of INX-08189 in healthy adults. The study will also look at how rapidly the drug breaks down in the body (pharmacokinetics or PK). The study objectives include:
- To evaluate the safety of single ascending oral doses of INX-08189 in healthy subjects
- To characterize the pharmacokinetic (PK) profile of single ascending oral doses of INX-08189 in healthy subjects
- To assess the food effect on the PK of a single oral dose of INX-08189
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INX-08189 | Experimental | Drug: INX-08189 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Healthy men and post-menopausal (absence of periods for more than 2 years) surgically sterile, or non-pregnant, non-lactating women using a reliable form of contraception (see Inclusion Criteria 9)
- Age 18 to 65 years, inclusive
- Normal (no clinically significant abnormalities) laboratory tests (chemistry, hematology and urinalysis)
- No clinically significant abnormalities on ECG (QTcB interval must be < 450 ms)
- Weight ≥ 50kg and Body Mass Index (BMI) of 19 to 30, inclusive
Key exclusion criteria (9 listed)
- Any active medical problem for which the subject is being evaluated and/or treated
- Calculated creatinine clearance (calculated using the IDMS traceable equation for the MDRD value) < 50 mL/min/1.73 m2
- Regular use of medications, prescription or non-prescription; no medication may be taken within 1 week prior to study dosing
- Use of alcohol within 48 hours prior to dosing (subjects must also agree to not use alcohol for 96 hours after dosing)
- Current lactation or breastfeeding
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 |
|---|---|---|
| INX-081893, 25 and 100 mg capsules; oral administration, single dose | Drug | INX-08189 |
| Placebomatching placebo capsules, oral administration, single dose | Drug | Placebo |
Primary outcome
Evaluate the safety of single ascending oral doses of INX-08189 in healthy subjects
Time frame: periodically over 14 days
Safety will be evaluated on the basis of adverse event (AE) incidence, changes in serum chemistry and hematology values, urinalysis results, and changes in vital signs and in electrocardiogram (ECG) findings.
Characterize the pharmacokinetic (PK) profile of single ascending oral doses of INX-08189 in healthy subjects
Time frame: periodically over 14 days
Including a determination of maximum observed plasma concentration (Cmax), time at which the maximum plasma concentration was observed (Tmax), time at which concentrations are first measurable in the plasma (Tlag), area under the plasma concentration-time curve from time 0 to time of last measurable plasma concentration (AUC 0-last) and elimination half-life (T 1/2) after single ascending oral doses.
Assess the effect of a high fat meal on the PK parameters
Time frame: periodically over 14 days
The effect of food (standard high-fat meal) on the absorption of INX-08189 will be evaluated
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 22 Jun 2012.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Brian Boehlecke, MD, MSPH study director
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing INX-08189 in people with Healthy, run by Bristol-Myers Squibb.
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 11 inclusion and 9 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 22 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
Evaluate the safety of single ascending oral doses of INX-08189 in healthy subjects (time frame: periodically over 14 days). The study lists 3 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 22 Jun 2012.