Healthy VolunteersPhase 1NCT02994381
A Single Dose Oral Excretion Balance Study of [14C]-RPC1063 in Healthy Male Adults
A Phase 1 study testing RPC1063 in people with Healthy Volunteers, run by Celgene at 1 site in United Kingdom.
Trial summary
This will be an open-label, non-randomized, single oral dose study in healthy male subjects. All subjects will receive a single oral dose of 10 mL of [14C]-RPC1063 Solution (0.1 mg/mL), containing NMT 1.3 MBq (37 μCi) 14C. Read more about this study
- Who is it for?
- Ages 30 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- RPC1063
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2016to Nov 2016
- 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 30 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is male
- Subject is 30 to 65 years of age
- Subject has a body weight of at least 50 kg; body mass index (BMI) of 18.0 to 32.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
- Subject is willing and able to communicate and participate in the whole study
- Subject has regular bowel movements (average stool production ≥1 and ≤3 stools per day)
- Subject has suitable veins for multiple cannulation as assessed by the investigator at screening
- Subject is able to comprehend the informed consent form, provide written informed consent, and able to comply with requirements of the study.
- Subject agrees to use an adequate method of contraception
Who cannot join
- Subject has received any investigational medicinal product (IMP) in a clinical research study within the previous 3 months
- Subject is a study site employee or an immediate family member of a study site or sponsor employee
- Subject has a history of any drug or alcohol abuse in the past 2 years
- Subject has regular alcohol consumption of >21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
- Subject is a current smoker or has smoked within the last 12 months; including cigarettes, e-cigarettes and nicotine replacement products. Positive cotinine test result at screening and admission
- Subject has radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 millisievert (mSv) in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study
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- Subjects has been enrolled in an absorption, distribution, metabolism and elimination (ADME) study in the last 12 months
- Subject has clinically significant abnormal biochemistry or haematology as judged by the investigator
- Subject has positive drugs of abuse test result
- Subject has positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
- Subject has evidence of renal impairment at screening and admission, as indicated by an estimated creatinine clearance (CLcr) of <90 mL/min using the Cockcroft-Gault equation
- Subject has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) concentration >1.25 × the ULN at screening
- Subject has history of cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease as judged by the investigator
- Subject has had serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
- Subject has presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever is allowed unless it is active
- Subject has donated or lost greater than 400 mL of blood within the previous 3 months
- Subject is taking, or has taken, any prescribed or over-the-counter drug (other than 2 g per 24 h paracetamol) dietary or herbal remedies within 14 days before IMP administration, or has taken St. John's wort within 28 days before IMP administration. Exceptions may apply on a case by case basis, if considered not to interfere with the objectives of the study, as agreed by the PI and sponsor's medical monitor.
- Subject fails to satisfy the investigator of fitness to participate for any other reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Single-Centre, Single Dose Oral Excretion Balance Study of [14C]-RPC1063 in Healthy Male Adults
This will be an open-label, non-randomized, single oral dose study in healthy male subjects.
All subjects will receive a single oral dose of 10 mL of [14C]-RPC1063 Solution (0.1 mg/mL), containing NMT 1.3 MBq (37 μCi) 14C.
Read the detailed description
Subjects will be screened for eligibility to participate in the study up to 28 days before dosing. Subjects will be admitted to the clinical unit on the morning of Day -1 prior to IMP administration. Subjects will be dosed on the morning of Day 1 following a standard breakfast, and will remain resident in the clinic until up to 168 h after dosing. It is planned that subjects will be released as a group when all subjects have achieved a mass balance cumulative recovery of >90% or if <1% of the dose administered has been collected in urine and faeces within 2 separate, consecutive 24 h periods. This may be earlier than 168 h post-dose but no sooner than 96 h post-dose. In this case, collection of all samples (blood, urine and faeces) will be stopped and the subjects will undergo discharge assessments. If this criteria has not been met by all subjects on Day 8, home collections of urine and faeces may be requested at the discretion of the investigator for individual subjects. A follow-up phone call will take place 5 to 10 days after discharge.
- Conditions
- Healthy Volunteers
- Being tested
- RPC1063
- Keywords
- Healthy Male Adults, 14C, RPC1063
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RPC1063Drug
| Study group | Role | What they receive |
|---|---|---|
| [14C]-RPC1063 Solution (0.1 g/mL) | Experimental | 1 mg; 10 mL [14C]-RPC1063 HCl oral dose containing NMT 1.3 MBq (37 μCi) 14C Receives: Drug: RPC1063 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of elimination of [14C]-RPC1063
Total recovery of radioactivity in urine and feces expressed as a percentage of total radioactive dose in each 24 h interval and cumulatively
Measured: Up to 4 weeks
Pharmacokinetic- amount of drug excreted
Cumulative amount of drug excreted unchanged in the drug in urine
Measured: Up to 4 weeks
Secondary outcomes (10)
Pharmacokinetic- Cmax
Maximum observed concentration
Measured: Up to 8 days
Pharmacokinetic- Tmax
Time at maximum observed concentration
Measured: Up to 8 days
Pharmacokinetic- AUC0-last
Area under the curve from 0 time to last measurable concentration
Measured: Up to 8 days
Pharmacokinetic- AUC0-inf
Area under the curve from 0 time extrapolated to infinity
Measured: Up to 8 days
Pharmacokinetic- λz
Elimination rate constant
Measured: Up to 8 days
Pharmacokinetic- t1/2
Terminal elimination half-life
Measured: Up to 8 days
Pharmacokinetic- CL/F
Clearance, the apparent volume cleared of parent drug per unit time after extravascular administration
Measured: Up to 8 days
Pharmacokinetic- Vz/F
The apparent volume of distribution after extravascular administration
Measured: Up to 8 days
Pharmacokinetic- CLr
Renal clearance
Measured: Up to 8 days
Adverse Events (AEs)
Number of participants with adverse events
Measured: Approximately 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2016 (estimated)
- Study startOct 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by CelgeneThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan Tran, Pharm.D, Study director, Celgene Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02994381
- Sponsor's protocol ID
- RPC01-1909
- Status last verified
- Jan 2017
- First submitted
- 13 Dec 2016
- Last updated
- 27 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-Centre, Single Dose Oral Excretion Balance Study of [14C]-RPC1063 in Healthy Male Adults
- ClinicalTrials.gov ID
- NCT02994381
- Acronym / sponsor ID
- RPC01-1909
- Conditions
- Healthy Volunteers
- Keywords
- Healthy Male Adults, 14C, RPC1063
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- Oct 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 15 Dec 2016 (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.
This will be an open-label, non-randomized, single oral dose study in healthy male subjects.
All subjects will receive a single oral dose of 10 mL of [14C]-RPC1063 Solution (0.1 mg/mL), containing NMT 1.3 MBq (37 μCi) 14C.
Detailed description
Subjects will be screened for eligibility to participate in the study up to 28 days before dosing. Subjects will be admitted to the clinical unit on the morning of Day -1 prior to IMP administration. Subjects will be dosed on the morning of Day 1 following a standard breakfast, and will remain resident in the clinic until up to 168 h after dosing. It is planned that subjects will be released as a group when all subjects have achieved a mass balance cumulative recovery of >90% or if <1% of the dose administered has been collected in urine and faeces within 2 separate, consecutive 24 h periods. This may be earlier than 168 h post-dose but no sooner than 96 h post-dose. In this case, collection of all samples (blood, urine and faeces) will be stopped and the subjects will undergo discharge assessments. If this criteria has not been met by all subjects on Day 8, home collections of urine and faeces may be requested at the discretion of the investigator for individual subjects. A follow-up phone call will take place 5 to 10 days after discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]-RPC1063 Solution (0.1 g/mL) | Experimental | Drug: RPC10631 mg; 10 mL [14C]-RPC1063 HCl oral dose containing NMT 1.3 MBq (37 μCi) 14C |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject is male
- Subject is 30 to 65 years of age
- Subject has a body weight of at least 50 kg; body mass index (BMI) of 18.0 to 32.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
- Subject is willing and able to communicate and participate in the whole study
- Subject has regular bowel movements (average stool production ≥1 and ≤3 stools per day)
Key exclusion criteria (18 listed)
- Subject has received any investigational medicinal product (IMP) in a clinical research study within the previous 3 months
- Subject is a study site employee or an immediate family member of a study site or sponsor employee
- Subject has a history of any drug or alcohol abuse in the past 2 years
- Subject has regular alcohol consumption of >21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
- Subject is a current smoker or has smoked within the last 12 months; including cigarettes, e-cigarettes and nicotine replacement products. Positive cotinine test result at screening and admission
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 |
|---|---|---|
| RPC1063 | Drug | [14C]-RPC1063 Solution (0.1 g/mL) |
Primary outcome
Percentage of elimination of [14C]-RPC1063
Time frame: Up to 4 weeks
Total recovery of radioactivity in urine and feces expressed as a percentage of total radioactive dose in each 24 h interval and cumulatively
Pharmacokinetic- amount of drug excreted
Time frame: Up to 4 weeks
Cumulative amount of drug excreted unchanged in the drug in urine
10 secondary outcomes
Pharmacokinetic- Cmax
Time frame: Up to 8 days
Pharmacokinetic- Tmax
Time frame: Up to 8 days
Pharmacokinetic- AUC0-last
Time frame: Up to 8 days
Pharmacokinetic- AUC0-inf
Time frame: Up to 8 days
Pharmacokinetic- λz
Time frame: Up to 8 days
Pharmacokinetic- t1/2
Time frame: Up to 8 days
Pharmacokinetic- CL/F
Time frame: Up to 8 days
Pharmacokinetic- Vz/F
Time frame: Up to 8 days
Pharmacokinetic- CLr
Time frame: Up to 8 days
Adverse Events (AEs)
Time frame: Approximately 2 months
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 27 Jan 2017.
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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.
Jonathan Tran, Pharm.D study director
Celgene Corporation
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 RPC1063 in people with Healthy Volunteers, run by Celgene 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 8 inclusion and 18 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 27 Jan 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. 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?
Percentage of elimination of [14C]-RPC1063 (time frame: Up to 4 weeks). 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 27 Jan 2017.