Arthritis, RheumatoidPhase 1NCT01934101
Phase 1 Dose Escalating Study to Assess Safety, Tolerability, Food Effect and PK of CHR-5154 in Healthy Male Volunteers
A Phase 1 study testing CHR-5154 in people with Arthritis, Rheumatoid, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
Primary Objective: To determine the safety and tolerability of single and multiple ascending oral doses of CHR-5154 in healthy volunteers. Secondary Objectives: To determine the pharmacokinetic profile of CHR-5154 and its metabolite CHR-5426. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- CHR-5154
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Aug 2013to 28 May 2014
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers aged 18-45.
- Non-smokers from at least three months before receiving the first dose of study drug and for the duration of the study.
- Body mass index (BMI) ≥ 18 and ≤ 32 kg/m2.
- Body weight ≥ 50 kg and ≤ 120 kg at screening.
- Able to voluntarily provide written informed consent to participate in the study.
- Must understand the purposes and risks of the study and agree to follow the restrictions and schedule of procedures as defined in the protocol, as confirmed during the informed consent process.
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- Sexually active male volunteers must use two highly effective methods of contraception with their partners throughout the study and for 90 days after completion of the study.
- Male volunteers must not donate sperm during the study and for 90 days after completion of the study.
- Must be willing to consent to have data entered into The Over Volunteering Prevention System (TOPS).
- The volunteer's primary care physician must confirm that there is nothing in their medical history that would preclude their enrolment into this clinical study
Who cannot join
- Volunteers with history or presence of significant cardiovascular disease, pulmonary, hepatic, gallbladder or biliary tract, renal, haematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychiatric disease or current infection.
- Laboratory values at screening or baseline which are deemed to be clinically significant.
- QTcF greater than 450 msec at screening.
- Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
- Current or history of drug or alcohol abuse or a positive drugs of abuse or alcohol test at screening or check-in.
- Participation in a clinical drug study during the 90 days preceding the initial dose in this study.
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- Any clinically significant illness within 30 days prior to study drug administration.
- Donation of blood or blood products within 90 days prior to study drug administration, or at any time during the study, except as required by this protocol.
- Volunteers who have a history or presence of any significant drug allergy.
- Use of any prescription or over-the-counter medication (including vitamins, herbal and mineral supplements) within 30 days prior to study drug administration until the end of the study, with the exception of occasional paracetamol approved by the Investigator.
- Strenuous exercise, as judged by the Investigator, within 72 hours prior to screening, within 72 hours prior to study drug administration and for the duration of the study until after the post-study medical.
- Weekly alcohol intake exceeding the equivalent of 21 units per week.
- Consumption of alcoholic beverages within 24 hours prior to study drug administration and during study confinement.
- Consumption of caffeine or xanthine-containing products within 24 hours prior to confinement and during study confinement.
- Consumption of grapefruit, grapefruit juice, Seville oranges, Seville orange marmalade or other products containing grapefruit or Seville oranges within 7 days prior to confinement and during study confinement.
- Volunteers who, in the opinion of the Investigator, are unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Double-blind, Randomised, Placebo-controlled, Dose Escalating Study to Assess the Safety and Tolerability of Single and Multiple Oral Doses of CHR-5154 and the Effect of the Fasted and Fed State on Pharmacokinetics of CHR-5154 and CHR-5426 in Healthy Male Volunteers
Primary Objective:
- To determine the safety and tolerability of single and multiple ascending oral doses of CHR-5154 in healthy volunteers.
Secondary Objectives:
- To determine the pharmacokinetic profile of CHR-5154 and its metabolite CHR-5426.
- To compare the pharmacokinetic profile of CHR-5154 and CHR-5426 after a single dose of CHR-5154 in the fed and fasted state.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- CHR-5154, Placebo
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHR-5154Drug
CHR-5154
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| CHR-5154 | Experimental | CHR-5154 Receives: Drug: CHR-5154 |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of volunteers with adverse events
Measured: upto 10 days in Single ascending dose phase and 16 days in the Multiple ascending dose phase
Secondary outcomes (2)
To determine the pharmacokinetic profile of CHR-5154 and its metabolite CHR-5426.
Measured: upto 48 hrs post dose
To compare the pharmacokinetic profile of CHR-5154 and CHR-5426 after a single dose of CHR-5154 in the fed and fasted state.
Measured: Upto 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2013 (estimated)
- Study start12 Aug 2013
- Primary completion28 May 2014
- Study completion28 May 2014
Why it stopped: Following the emergence of an unexpected pharmacodynamic effect, the sponsor has decided to conclude the study early without fully achieving its objective
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01934101
- Sponsor's protocol ID
- 201302
- Status last verified
- May 2017
- First submitted
- 15 Jul 2013
- Last updated
- 15 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Double-blind, Randomised, Placebo-controlled, Dose Escalating Study to Assess the Safety and Tolerability of Single and Multiple Oral Doses of CHR-5154 and the Effect of the Fasted and Fed State on Pharmacokinetics of CHR-5154 and CHR-5426 in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01934101
- Acronym / sponsor ID
- 201302
- Conditions
- Arthritis, Rheumatoid
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Following the emergence of an unexpected pharmacodynamic effect, the sponsor has decided to conclude the study early without fully achieving its objective
- Enrolment
- 64 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 12 Aug 2013 (actual)
- Primary completion
- 28 May 2014 (actual)
- Study completion
- 28 May 2014 (actual)
- First posted
- 4 Sep 2013 (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.
Primary Objective:
- To determine the safety and tolerability of single and multiple ascending oral doses of CHR-5154 in healthy volunteers.
Secondary Objectives:
- To determine the pharmacokinetic profile of CHR-5154 and its metabolite CHR-5426.
- To compare the pharmacokinetic profile of CHR-5154 and CHR-5426 after a single dose of CHR-5154 in the fed and fasted state.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHR-5154 | Experimental | Drug: CHR-5154CHR-5154 |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Healthy male volunteers aged 18-45.
- Non-smokers from at least three months before receiving the first dose of study drug and for the duration of the study.
- Body mass index (BMI) ≥ 18 and ≤ 32 kg/m2.
- Body weight ≥ 50 kg and ≤ 120 kg at screening.
- Able to voluntarily provide written informed consent to participate in the study.
Key exclusion criteria (16 listed)
- Volunteers with history or presence of significant cardiovascular disease, pulmonary, hepatic, gallbladder or biliary tract, renal, haematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychiatric disease or current infection.
- Laboratory values at screening or baseline which are deemed to be clinically significant.
- QTcF greater than 450 msec at screening.
- Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
- Current or history of drug or alcohol abuse or a positive drugs of abuse or alcohol test at screening or check-in.
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-5154CHR-5154 | Drug | CHR-5154 |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Number of volunteers with adverse events
Time frame: upto 10 days in Single ascending dose phase and 16 days in the Multiple ascending dose phase
2 secondary outcomes
To determine the pharmacokinetic profile of CHR-5154 and its metabolite CHR-5426.
Time frame: upto 48 hrs post dose
To compare the pharmacokinetic profile of CHR-5154 and CHR-5426 after a single dose of CHR-5154 in the fed and fasted state.
Time frame: Upto 48 hours
Results and safety
The study was stopped early (reason given: Following the emergence of an unexpected pharmacodynamic effect, the sponsor has decided to conclude the study early without fully achieving its objective). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
- Results for study 201302 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
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-5154 in people with Arthritis, Rheumatoid, run by GlaxoSmithKline at 1 site in United Kingdom.
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: stopped early, as of the sponsor's last update on 15 May 2017. 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 Kingdom. 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 was stopped early (reason given: Following the emergence of an unexpected pharmacodynamic effect, the sponsor has decided to conclude the study early without fully achieving its objective). Results are not available in the source record.
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?
Number of volunteers with adverse events (time frame: upto 10 days in Single ascending dose phase and 16 days in the Multiple ascending dose phase). 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 15 May 2017.