Healthy VolunteersPhase 1NCT04649216
Excretion Balance, PK and Metabolism of a Single Oral Dose of [14C]PCO371
A Phase 1 study testing PCO371 and [14C]PCO371 in people with Healthy Volunteers, run by Chugai Pharmaceutical at 1 site in United Kingdom.
Trial summary
This is a Phase I single center, open-label, non-randomized study in healthy male subjects, designed to evaluate the mass balance recovery, PK, metabolism and absolute bioavailability of single oral doses of PCO371. It is planned to enroll 12 subjects, with 6 subjects in each of 2 study parts. Read more about this study
- Who is it for?
- Ages 40 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- PCO371 and [14C]PCO371
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Nov 2020to 30 Dec 2020
- 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 40 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males
- Aged 40 to 60 years inclusive at the time of signing informed consent.
- Body mass index (BMI) of 18.5 to 30.0 kg/m2 as measured at screening.
- Must be willing and able to communicate and participate in the whole study.
- Subjects must have regular bowel movements (i.e. average stool production of >=1 and <=3 stools per day).
- Must provide written informed consent.
- Must agree to adhere to the contraception requirements.
- Subjects must regularly consume 2 or more units of alcohol per week.
Who cannot join
- Subjects who have taken any experimental (non-approved) drug (including placebo) either within 90 days before the administration of the study drug, or 6 times the T1/2 of the experimental drug, whichever is longer.
- Subjects who have previously been administered IMP in this study. Subjects are not permitted to be dosed in both Part 1 and Part 2 of the study.
- Subjects who have been administered IMP in any 14C-labelled ADME in the last 12 months.
- Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 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 2017, shall participate in the study.
- Subjects who do not have suitable veins for multiple venipunctures / cannulation as assessed by the investigator or delegate at screening.
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- Clinically significant abnormal clinical chemistry, hematology, coagulation or urinalysis as judged by the investigator at screening or admission.
- Abnormal (outside of reference range) serum calcium or corrected calcium as measured at admission or screening.
- Elevated (> 2.5 × upper limit of normal [ULN]) alkaline phosphatase at admission or screening. Subjects with Gilbert's syndrome or elevated (above the ULN) aspartate aminotransferase (AST), ALT or total bilirubin at admission or screening.
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results.
- Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance of <60 mL/min using the Cockcroft-Gault equation.
- Confirmed positive drugs of abuse test result.
- History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, immunologic, metabolism, endocrine, neurological or psychiatric disorder, as judged by the investigator, blood dyscrasia, risk factors for osteosarcoma as judged by the investigator.
- Evidence or any history of active diseases that might affect calcium, bone metabolism, or calcium-phosphate homeostasis.
- Use of anti-coagulants (e.g. heparins, warfarin, and thrombolytic agents), anti-platelet medications (e.g. argatroban and ticlopidine), nonsteroidal anti-inflammatory drugs and aspirin within 2 weeks (or within 6 times the T1/2 of the drug, whichever is longer) prior to study drug administration.
- Subjects who have taken any inducers of CYP3A4, P glycoprotein (e.g. St. John's wort), or BCRP within 1 month prior to study drug administration, or taken any inhibitors of CYP3A4, P-glycoprotein, or BCRP (including herbal products, diets, and drinks e.g. tonic water) within 2 weeks prior to study drug administration (or within 6 times the T1/2 of the drugs mentioned above, whichever is longer).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Single-Center, Open-Label Study Investigating the Excretion Balance, Pharmacokinetics (PK) and Metabolism of a Single Oral Dose of [14C]PCO371 and PK of an Intravenous (IV) Tracer of [14C]PCO371 in Healthy Male Subjects
This is a Phase I single center, open-label, non-randomized study in healthy male subjects, designed to evaluate the mass balance recovery, PK, metabolism and absolute bioavailability of single oral doses of PCO371. It is planned to enroll 12 subjects, with 6 subjects in each of 2 study parts. Subjects in Part 1 will receive a single oral dose of [14C]PCO371 Oral Solution. Subjects in Part 2 will receive a single oral dose of PCO371 capsules, followed by a single intravenous infusion of [14C]PCO371 Solution for Infusion over 10 min, starting 2 h post-oral dose. The study parts may be dosed in any order for logistical reasons (e.g. Part 2 may be dosed before Part 1). No subject will be permitted to take part in both study parts.
- Conditions
- Healthy Volunteers
- Being tested
- PCO371, [14C]PCO371
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCO371Drug
PCO371 Capsule
[14C]PCO371Drug
[14C]PCO371 Oral solution
[14C]PCO371Drug
[14C]PCO371 Solution for infusion
| Study group | Role | What they receive |
|---|---|---|
| Mass Balance | Experimental | Subjects will receive a single oral dose of [14C]PCO371 Oral Solution. Receives: Drug: [14C]PCO371 |
| Absolute Bioavailability and Mass Balance | Experimental | Subjects will receive a single oral dose of PCO371 capsules, followed by a single IV infusion of [14C]PCO371 over 10 min, starting 2 h post-oral dose. Receives: Drug: PCO371; Drug: [14C]PCO371 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mass balance data for [14C]PCO371 Oral solution in urine
Amount of total radioactivity excreted in urine(Ae(urine)) and Ae(urine) expressed as a percentage of the radioactive dose administered (%Ae(urine)), cumulative amount of total radioactivity excreted in urine (CumAe(urine)) and CumAe(urine)expressed as a percentage of the radioactive dose administered (Cum%Ae(urine)) following oral administration of [14C]PCO371 Oral Solution.
Measured: 1 week
Mass balance data for [14C]PCO371 Oral solution in feces
Amount of total radioactivity excreted in feces(Ae(feces)) and Ae(feces) expressed as a percentage of the radioactive dose administered (%Ae(feces)), cumulative amount of total radioactivity excreted in feces (CumAe(feces)) and CumAe(feces)expressed as a percentage of the radioactive dose administered (Cum%Ae(feces)) following oral administration of [14C]PCO371 Oral Solution.
Measured: 5 weeks
Mass balance data for [14C]PCO371 Oral solution in urine and feces combined
Amount of total radioactivity excreted in urine and feces combined(Ae(total)) and Ae(total) expressed as a percentage of the radioactive dose administered (%Ae(total)), cumulative amount of total radioactivity excreted in urine and feces combined (CumAe(total)) and CumAe(total)expressed as a percentage of the radioactive dose administered (Cum%Ae(total)) following oral administration of [14C]PCO371 Oral Solution.
Measured: 5 weeks
Absolute bioavailability (F) for PCO371
Time of maximum observed concentration for PCO371 and a metabolite in plasma and for total radioactivity in plasma and whole blood following oral administration of [14C]PCO371 Oral Solution
Measured: 1 week
Secondary outcomes (37)
Pharmacokinetic data for [14C]PCO371 Oral Solution; Tmax
Time of maximum observed concentration for PCO371 and a metabolite in plasma and for total radioactivity in plasma and whole blood following oral administration of [14C]PCO371 Oral Solution
Measured: 1 week
Pharmacokinetic data for [14C]PCO371 Oral Solution; Cmax
Maximum observed concentration for PCO371 and a metabolite in plasma and for total radioactivity in plasma and whole blood following oral administration of [14C]PCO371 Oral Solution
Measured: 1 week
Pharmacokinetic data for [14C]PCO371 Oral Solution; AUC(0-last)
Area under the curve from time 0 to the time of last measurable concentration for PCO371 and a metabolite in plasma and for total radioactivity in plasma and whole blood following oral administration of [14C]PCO371 Oral Solution
Measured: 1 week
Pharmacokinetic data for [14C]PCO371 Oral Solution; AUC(0-inf)
Area under the curve from time 0 extrapolated to infinity for PCO371 and a metabolite in plasma and for total radioactivity in plasma and whole blood following oral administration of [14C]PCO371 Oral Solution
Measured: 1 week
Pharmacokinetic data for [14C]PCO371 Oral Solution; T1/2
Terminal elimination half-life for PCO371 and a metabolite in plasma and for total radioactivity in plasma and whole blood following oral administration of [14C]PCO371 Oral Solution
Measured: 1 week
Pharmacokinetic data for [14C]PCO371 Oral Solution; Cmax ratio
Ratio of PCO371: total radioactivity and ratio of a metabolite: total radioactivity based on Cmax following oral administration of [14C]PCO371 Oral Solution
Measured: 1 week
Pharmacokinetic data for [14C]PCO371 Oral Solution; AUC ratio
Ratio of whole blood: plasma total radioactivity based on Cmax following oral administration of [14C]PCO371 Oral Solution
Measured: 1 week
Pharmacokinetic data for [14C]PCO371 Oral Solution; B:P Cmax ratio
Ratio of whole blood:plasma total radioactivity based on Cmax following oral administration of [14C]PCO371 Oral Solution
Measured: 1 week
Pharmacokinetic data for [14C]PCO371 Oral Solution; B:P AUC ratio
Ratio of whole blood:plasma total radioactivity based on AUC following oral administration of [14C]PCO371 Oral Solution
Measured: 1 week
Metabolite profiling of plasma, urine and feces
The chemical structure of each metabolite accounting for >=5% of circulating radioactivity in plasma and accounting for >=5% of the dose in the urine and feces
Measured: 1 week
Intravenous pharmacokinetic data for [14C]PCO371 Solution for Infusion; C0
Concentration at end of infusion of [14C]PCO371 and total radioactivity in plasma following oral dose of PCO371 capsules and intravenous infusion of [14C]PCO371 Solution for Infusion.
Measured: 1 week
Intravenous pharmacokinetic data for [14C]PCO371 Solution for Infusion; AUC(0-last)
Area under the curve from time 0 to the time of last measurable concentration of [14C]PCO371 and total radioactivity in plasma following oral dose of PCO371 capsules and intravenous infusion of [14C]PCO371 Solution for Infusion.
Measured: 1 week
Intravenous pharmacokinetic data for [14C]PCO371 Solution for Infusion; AUC(0-inf)
Area under the curve from time 0 extrapolated to infinity of [14C]PCO371 and total radioactivity in plasma following oral dose of PCO371 capsules and intravenous infusion of [14C]PCO371 Solution for Infusion.
Measured: 1 week
Intravenous pharmacokinetic data for [14C]PCO371 Solution for Infusion; T1/2
Terminal elimination half-life of [14C]PCO371 and total radioactivity in plasma following oral dose of PCO371 capsules and intravenous infusion of [14C]PCO371 Solution for Infusion.
Measured: 1 week
Intravenous pharmacokinetic data for [14C]PCO371 Solution for Infusion; CL
Total body clearance calculated after a single IV administration of [14C]PCO371 in plasma following oral dose of PCO371 capsules and intravenous infusion of [14C]PCO371 Solution for Infusion.
Measured: 1 week
Intravenous pharmacokinetic data for [14C]PCO371 Solution for Infusion; Vz
Volume of distribution based on the terminal phase calculated using AUC(0-inf) after a single IV administration of [14C]PCO371 in plasma following oral dose of PCO371 capsules and intravenous infusion of [14C]PCO371 Solution for Infusion.
Measured: 1 week
Oral pharmacokinetic data for PCO371 capsule; Tmax
Time of maximum observed concentration for plasma concentration of PCO371 and a metabolite following oral dose of PCO371 capsules and intravenous infusion of [14C]PCO371 Solution for Infusion.
Measured: 1 week
Oral pharmacokinetic data for PCO371 capsule; Cmax
Maximum observed concentration for plasma concentration of PCO371 and a metabolite following oral dose of PCO371 capsules and intravenous infusion of [14C]PCO371 Solution for Infusion.
Measured: 1 week
Oral pharmacokinetic data for PCO371 capsule; AUC(0-last)
Area under the curve from time 0 to the time of last measurable concentration for plasma concentration of PCO371 and a metabolite following oral dose of PCO371 capsules and intravenous infusion of [14C]PCO371 Solution for Infusion.
Measured: 1 week
Oral pharmacokinetic data for PCO371 capsule; AUC(0-inf)
Area under the curve from time 0 extrapolated to infinity for plasma concentration of PCO371 and a metabolite following oral dose of PCO371 capsules and intravenous infusion of [14C]PCO371 Solution for Infusion.
Measured: 1 week
Oral pharmacokinetic data for PCO371 capsule; T1/2
Terminal elimination half-life for plasma concentration of PCO371 and a metabolite following oral dose of PCO371 capsules and intravenous infusion of [14C]PCO371 Solution for Infusion.
Measured: 1 week
Mass balance data for [14C]PCO371 Solution for Infusion in urine
Cumulative amount of total radioactivity excreted in urine expressed as a percentage of the radioactive dose administered (Cum%Ae(urine)) and cumulative amount of [14C]PCO371 excreted in urine expressed as a percentage of the [14C]PCO371 dose administered (Cum%Ae([14C]PCO371 urine))
Measured: 1 week
Mass balance data for [14C]PCO371 Solution for Infusion in feces
Cumulative amount of total radioactivity excreted in feces expressed as a percentage of the radioactive dose administered (Cum%Ae(feces)) and cumulative amount of [14C]PCO371 excreted in feces expressed as a percentage of the [14C]PCO371 dose administered (Cum%Ae([14C]PCO371 feces))
Measured: 5 weeks
Safety data for PCO371; Adverse event monitoring
Incidence and severity of adverse events
Measured: 6 weeks
Safety data for PCO371; Incidence of laboratory abnormalities
Incidence of laboratory abnormalities, based on clinical laboratory tests ( i.e. hematology, clinical chemistry, coagulation and urinalysis test results)
Measured: 6 weeks
Safety data for PCO371; 12-lead ECGs (Ventricular Rate)
Abnormality in Electrocardiograms (ECGs) Interpretation based on Ventricular Rate
Measured: 6 weeks
Safety data for PCO371; 12-lead ECGs (PR interval)
Abnormality in Electrocardiograms (ECGs) Interpretation based on PR interval
Measured: 6 weeks
Safety data for PCO371; 12-lead ECGs (QRS Duration)
Abnormality in Electrocardiograms (ECGs) Interpretation based on QRS Duration
Measured: 6 weeks
Safety data for PCO371; 12-lead ECGs (QT interval)
Abnormality in Electrocardiograms (ECGs) Interpretation based on QT interval
Measured: 6 weeks
Safety data for PCO371; 12-lead ECGs (QRS Axis)
Abnormality in Electrocardiograms (ECGs) Interpretation based on QRS Axis
Measured: 6 weeks
Safety data for PCO371; 12-lead ECGs (QTcF interval)
Abnormality in Electrocardiograms (ECGs) Interpretation based on QTcF interval
Measured: 6 weeks
Safety data for PCO371; 12-lead ECGs (Rhythm)
Abnormality in Electrocardiograms (ECGs) Interpretation based on Rhythm
Measured: 6 weeks
Safety data for PCO371; Vital signs (Systolic blood pressure)
Abnormality in Systolic blood pressure
Measured: 6 weeks
Safety data for PCO371; Vital signs (Diastolic blood pressure)
Abnormality in Diastolic blood pressure
Measured: 6 weeks
Safety data for PCO371; Vital signs (Heart Rate)
Abnormality in Heart Rate
Measured: 6 weeks
Safety data for PCO371; Vital signs (Oral temperature)
Abnormality in Oral temperature
Measured: 6 weeks
Safety data for PCO371; Presense of abnormalities in Physical examinations
Abnormality in Physical examination findings
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start25 Nov 2020
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chugai Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chugai Pharma Europe Ltd., Study director, clinical-trials@chugai-pharm.co.jp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04649216
- Sponsor's protocol ID
- PCO006EU
- Status last verified
- Feb 2021
- First submitted
- 11 Nov 2020
- Last updated
- 1 Mar 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds\_request.html).
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-Center, Open-Label Study Investigating the Excretion Balance, Pharmacokinetics (PK) and Metabolism of a Single Oral Dose of [14C]PCO371 and PK of an Intravenous (IV) Tracer of [14C]PCO371 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT04649216
- Acronym / sponsor ID
- PCO006EU
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Chugai PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 25 Nov 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 2 Dec 2020 (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.
This is a Phase I single center, open-label, non-randomized study in healthy male subjects, designed to evaluate the mass balance recovery, PK, metabolism and absolute bioavailability of single oral doses of PCO371. It is planned to enroll 12 subjects, with 6 subjects in each of 2 study parts. Subjects in Part 1 will receive a single oral dose of [14C]PCO371 Oral Solution. Subjects in Part 2 will receive a single oral dose of PCO371 capsules, followed by a single intravenous infusion of [14C]PCO371 Solution for Infusion over 10 min, starting 2 h post-oral dose. The study parts may be dosed in any order for logistical reasons (e.g. Part 2 may be dosed before Part 1). No subject will be permitted to take part in both study parts.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mass Balance | Experimental | Drug: [14C]PCO371Subjects will receive a single oral dose of [14C]PCO371 Oral Solution. |
| Absolute Bioavailability and Mass Balance | Experimental | Drug: PCO371, Drug: [14C]PCO371Subjects will receive a single oral dose of PCO371 capsules, followed by a single IV infusion of [14C]PCO371 over 10 min, starting 2 h post-oral dose. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy males
- Aged 40 to 60 years inclusive at the time of signing informed consent.
- Body mass index (BMI) of 18.5 to 30.0 kg/m2 as measured at screening.
- Must be willing and able to communicate and participate in the whole study.
- Subjects must have regular bowel movements (i.e. average stool production of >=1 and <=3 stools per day).
Key exclusion criteria (16 listed)
- Subjects who have taken any experimental (non-approved) drug (including placebo) either within 90 days before the administration of the study drug, or 6 times the T1/2 of the experimental drug, whichever is longer.
- Subjects who have previously been administered IMP in this study. Subjects are not permitted to be dosed in both Part 1 and Part 2 of the study.
- Subjects who have been administered IMP in any 14C-labelled ADME in the last 12 months.
- Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 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 2017, shall participate in the study.
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 |
|---|---|---|
| PCO371PCO371 Capsule | Drug | Absolute Bioavailability and Mass Balance |
| [14C]PCO371[14C]PCO371 Oral solution | Drug | Mass Balance |
| [14C]PCO371[14C]PCO371 Solution for infusion | Drug | Absolute Bioavailability and Mass Balance |
Primary outcome
Mass balance data for [14C]PCO371 Oral solution in urine
Time frame: 1 week
Amount of total radioactivity excreted in urine(Ae(urine)) and Ae(urine) expressed as a percentage of the radioactive dose administered (%Ae(urine)), cumulative amount of total radioactivity excreted in urine (CumAe(urine)) and CumAe(urine)expressed as a percentage of the radioactive dose administered (Cum%Ae(urine)) following oral administration of [14C]PCO371 Oral Solution.
Mass balance data for [14C]PCO371 Oral solution in feces
Time frame: 5 weeks
Amount of total radioactivity excreted in feces(Ae(feces)) and Ae(feces) expressed as a percentage of the radioactive dose administered (%Ae(feces)), cumulative amount of total radioactivity excreted in feces (CumAe(feces)) and CumAe(feces)expressed as a percentage of the radioactive dose administered (Cum%Ae(feces)) following oral administration of [14C]PCO371 Oral Solution.
Mass balance data for [14C]PCO371 Oral solution in urine and feces combined
Time frame: 5 weeks
Amount of total radioactivity excreted in urine and feces combined(Ae(total)) and Ae(total) expressed as a percentage of the radioactive dose administered (%Ae(total)), cumulative amount of total radioactivity excreted in urine and feces combined (CumAe(total)) and CumAe(total)expressed as a percentage of the radioactive dose administered (Cum%Ae(total)) following oral administration of [14C]PCO371 Oral Solution.
Absolute bioavailability (F) for PCO371
Time frame: 1 week
Time of maximum observed concentration for PCO371 and a metabolite in plasma and for total radioactivity in plasma and whole blood following oral administration of [14C]PCO371 Oral Solution
37 secondary outcomes
Pharmacokinetic data for [14C]PCO371 Oral Solution; Tmax
Time frame: 1 week
Pharmacokinetic data for [14C]PCO371 Oral Solution; Cmax
Time frame: 1 week
Pharmacokinetic data for [14C]PCO371 Oral Solution; AUC(0-last)
Time frame: 1 week
Pharmacokinetic data for [14C]PCO371 Oral Solution; AUC(0-inf)
Time frame: 1 week
Pharmacokinetic data for [14C]PCO371 Oral Solution; T1/2
Time frame: 1 week
Pharmacokinetic data for [14C]PCO371 Oral Solution; Cmax ratio
Time frame: 1 week
Pharmacokinetic data for [14C]PCO371 Oral Solution; AUC ratio
Time frame: 1 week
Pharmacokinetic data for [14C]PCO371 Oral Solution; B:P Cmax ratio
Time frame: 1 week
Pharmacokinetic data for [14C]PCO371 Oral Solution; B:P AUC ratio
Time frame: 1 week
Metabolite profiling of plasma, urine and feces
Time frame: 1 week
Intravenous pharmacokinetic data for [14C]PCO371 Solution for Infusion; C0
Time frame: 1 week
Intravenous pharmacokinetic data for [14C]PCO371 Solution for Infusion; AUC(0-last)
Time frame: 1 week
Intravenous pharmacokinetic data for [14C]PCO371 Solution for Infusion; AUC(0-inf)
Time frame: 1 week
Intravenous pharmacokinetic data for [14C]PCO371 Solution for Infusion; T1/2
Time frame: 1 week
Intravenous pharmacokinetic data for [14C]PCO371 Solution for Infusion; CL
Time frame: 1 week
Intravenous pharmacokinetic data for [14C]PCO371 Solution for Infusion; Vz
Time frame: 1 week
Oral pharmacokinetic data for PCO371 capsule; Tmax
Time frame: 1 week
Oral pharmacokinetic data for PCO371 capsule; Cmax
Time frame: 1 week
Oral pharmacokinetic data for PCO371 capsule; AUC(0-last)
Time frame: 1 week
Oral pharmacokinetic data for PCO371 capsule; AUC(0-inf)
Time frame: 1 week
Oral pharmacokinetic data for PCO371 capsule; T1/2
Time frame: 1 week
Mass balance data for [14C]PCO371 Solution for Infusion in urine
Time frame: 1 week
Mass balance data for [14C]PCO371 Solution for Infusion in feces
Time frame: 5 weeks
Safety data for PCO371; Adverse event monitoring
Time frame: 6 weeks
Safety data for PCO371; Incidence of laboratory abnormalities
Time frame: 6 weeks
Safety data for PCO371; 12-lead ECGs (Ventricular Rate)
Time frame: 6 weeks
Safety data for PCO371; 12-lead ECGs (PR interval)
Time frame: 6 weeks
Safety data for PCO371; 12-lead ECGs (QRS Duration)
Time frame: 6 weeks
Safety data for PCO371; 12-lead ECGs (QT interval)
Time frame: 6 weeks
Safety data for PCO371; 12-lead ECGs (QRS Axis)
Time frame: 6 weeks
Safety data for PCO371; 12-lead ECGs (QTcF interval)
Time frame: 6 weeks
Safety data for PCO371; 12-lead ECGs (Rhythm)
Time frame: 6 weeks
Safety data for PCO371; Vital signs (Systolic blood pressure)
Time frame: 6 weeks
Safety data for PCO371; Vital signs (Diastolic blood pressure)
Time frame: 6 weeks
Safety data for PCO371; Vital signs (Heart Rate)
Time frame: 6 weeks
Safety data for PCO371; Vital signs (Oral temperature)
Time frame: 6 weeks
Safety data for PCO371; Presense of abnormalities in Physical examinations
Time frame: 6 weeks
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 1 Mar 2021.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds_request.html).
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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.
Chugai Pharma Europe Ltd. study director
clinical-trials@chugai-pharm.co.jp
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 PCO371 and [14C]PCO371 in people with Healthy Volunteers, run by Chugai Pharmaceutical 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 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: finished, as of the sponsor's last update on 1 Mar 2021. 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?
Mass balance data for [14C]PCO371 Oral solution in urine (time frame: 1 week). The study lists 4 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 1 Mar 2021.