ImmunosciencePhase 1NCT03196557
A Study to Assess the Pharmacodynamics (PD) of Prednisoline in Healthy Male Subject
A Phase 1 study testing Prenisolone in people with Immunoscience, run by Bristol-Myers Squibb at 2 sites in United States.
Trial summary
The purpose of this study is to assess the pharmacodynamics of Prednisolone in 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
- Immunoscience
- What is being tested?
- Prenisolone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Mar 2008to 5 May 2008
- 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
- Healthy male subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
- Body Mass Index (BMI) of 18 to 30 kilogram / square meter (kg/m2), inclusive
- Signed informed consent
Who cannot join
- Women
- Any significant acute or chronic medical illness
- Current or recent (within 3 months) gastrointestinal disease including peptic ulcer
- Other protocol inclusion/exclusion criteria may apply
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Ppd Development
Austin, Texas, 78744
Local Institution
Austin, Texas, 78759
About this study
Official title: An Experimental Medicine Study to Assess the Pharmacodynamics Following Administration of Multiple Doses of Prednisolone to Healthy Male Subjects
The purpose of this study is to assess the pharmacodynamics of Prednisolone in healthy male subjects
- Conditions
- Immunoscience
- Being tested
- Prenisolone, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrenisoloneDrug
Specified dose on specified days
PlaceboDrug
Specified dose on dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Specified dose on specified days Receives: Drug: Prenisolone |
| Arm B | Placebo comparator | Specified dose on specified days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukin 1 beta
As measured by flow cytometry
Measured: Up to 32 days
Tumor necrosis factor-alpha
As measured by flow cytometry
Measured: Up to 32 days
Receptor activator of nuclear factor-kB (RANK)
As measured by flow cytometry
Measured: Up to 32 days
Receptor activator of nuclear factor-kB ligand (RANKL)
As measured by flow cytometry
Measured: Up to 32 days
Osteoprotegrin (OPG)
As measured by flow cytometry
Measured: Up to 32 days
Lipopolysaccharide Induced Cytokine Production
As measured by blood concentration
Measured: Up to 32 days
Cell Populations
As measured by flow cytometry
Measured: Up to 32 days
Oral glucose tolerance test
Assessed by central labortatory
Measured: Up to 32 days
Cortisol
As measured by the level of the hormone cortisol in the blood
Measured: Up to 32 days
Adrenocorticotropic hormone
As measured by the level of the hormone in the blood
Measured: Up to 32 days
Osteocalcin
As measured by blood concentration
Measured: Up to 32 days
N-terminal Pro-Collagen Peptide (PINP)
As measured by blood concentration
Measured: Up to 32 days
Propetide type I C-term Pro-collagen Peptide (CICP)
As measured by blood concentration
Measured: Up to 32 days
Bone-specific alkaline phosphatase
As measured by blood concentration
Measured: Up to 32 days
Urinary deoxypyridinoline
As measured by urine concentration
Measured: Up to 32 days
C Telopeptide of Collagen Type II (CTX-II)
As measured by urine concentration
Measured: Up to 32 days
Calcium
As measured by urine concentration
Measured: Up to 32 days
Creatinine
As measured by urine concentration
Measured: Up to 32 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start31 Mar 2008
- Primary completion5 May 2008
- Study completion5 May 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ImmunoscienceStudies 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03196557
- Sponsor's protocol ID
- IM124-001
- Status last verified
- Dec 2019
- First submitted
- 21 Jun 2017
- Last updated
- 6 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Hu Y, Carman JA, Holloway D, Kansal S, Fan L, Goldstine C, Lee D, Somerville JE, Latek R, Townsend R, Johnsen A, Connolly S, Bandyopadhyay S, Shadick N, Weinblatt ME, Furie R, Nadler SG. Development of a Molecular Signature to Monitor Pharmacodynamic Responses Mediated by In Vivo Administration of Glucocorticoids. Arthritis Rheumatol. 2018 Aug;70(8):1331-1342. doi: 10.1002/art.40476. Epub 2018 Jul 12.
PubMed 29534336
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Experimental Medicine Study to Assess the Pharmacodynamics Following Administration of Multiple Doses of Prednisolone to Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03196557
- Acronym / sponsor ID
- IM124-001
- Conditions
- Immunoscience
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2008 (actual)
- Primary completion
- 5 May 2008 (actual)
- Study completion
- 5 May 2008 (actual)
- First posted
- 22 Jun 2017 (actual)
- 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 assess the pharmacodynamics of Prednisolone in healthy male subjects
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: PrenisoloneSpecified dose on specified days |
| Arm B | Placebo comparator | Drug: PlaceboSpecified dose on specified days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
- Body Mass Index (BMI) of 18 to 30 kilogram / square meter (kg/m2), inclusive
- Signed informed consent
Key exclusion criteria (4 listed)
- Women
- Any significant acute or chronic medical illness
- Current or recent (within 3 months) gastrointestinal disease including peptic ulcer
- Other protocol inclusion/exclusion criteria may apply
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 |
|---|---|---|
| PrenisoloneSpecified dose on specified days | Drug | Arm A |
| PlaceboSpecified dose on dose on specified days | Drug | Arm B |
Primary outcome
Interleukin 1 beta
Time frame: Up to 32 days
As measured by flow cytometry
Tumor necrosis factor-alpha
Time frame: Up to 32 days
As measured by flow cytometry
Receptor activator of nuclear factor-kB (RANK)
Time frame: Up to 32 days
As measured by flow cytometry
Receptor activator of nuclear factor-kB ligand (RANKL)
Time frame: Up to 32 days
As measured by flow cytometry
Osteoprotegrin (OPG)
Time frame: Up to 32 days
As measured by flow cytometry
Lipopolysaccharide Induced Cytokine Production
Time frame: Up to 32 days
As measured by blood concentration
Cell Populations
Time frame: Up to 32 days
As measured by flow cytometry
Oral glucose tolerance test
Time frame: Up to 32 days
Assessed by central labortatory
Cortisol
Time frame: Up to 32 days
As measured by the level of the hormone cortisol in the blood
Adrenocorticotropic hormone
Time frame: Up to 32 days
As measured by the level of the hormone in the blood
Osteocalcin
Time frame: Up to 32 days
As measured by blood concentration
N-terminal Pro-Collagen Peptide (PINP)
Time frame: Up to 32 days
As measured by blood concentration
Propetide type I C-term Pro-collagen Peptide (CICP)
Time frame: Up to 32 days
As measured by blood concentration
Bone-specific alkaline phosphatase
Time frame: Up to 32 days
As measured by blood concentration
Urinary deoxypyridinoline
Time frame: Up to 32 days
As measured by urine concentration
C Telopeptide of Collagen Type II (CTX-II)
Time frame: Up to 32 days
As measured by urine concentration
Calcium
Time frame: Up to 32 days
As measured by urine concentration
Creatinine
Time frame: Up to 32 days
As measured by urine concentration
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 6 Dec 2019.
- Derived from this study: PubMed 29534336Hu Y, Carman JA, Holloway D, Kansal S, Fan L, Goldstine C, Lee D, Somerville JE, Latek R, Townsend R, Johnsen A, Connolly S, Bandyopadhyay S, Shadick N, Weinblatt ME, Furie R, Nadler SG. Development of a Molecular Signature to Monitor Pharmacodynamic Responses Mediated by In Vivo Administration of Glucocorticoids. Arthritis Rheumatol. 2018 Aug;70(8):1331-1342. doi: 10.1002/art.40476. Epub 2018 Jul 12.
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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Prenisolone in people with Immunoscience, run by Bristol-Myers Squibb at 2 sites 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 3 inclusion and 4 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 6 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Interleukin 1 beta (time frame: Up to 32 days). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03196557, which also lists 1 linked publication.
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 6 Dec 2019.