PK for FG-4592Phase 1NCT02161796
A Study to Evaluate the Dose-proportionality and Effects of FG-4592 in Healthy Young and Elderly Male and Female Subjects
A Phase 1 study testing FG-4592 in people with PK for FG-4592 and Healthy Subjects, run by Astellas Pharma Europe B.V. at 1 site in Germany.
Trial summary
This study evaluates the concentration of FG-4592 in the blood over a certain period after the intake of different doses, and assesses the effects, the safety and the tolerability of the study drug in healthy young and elderly male and female subjects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- PK for FG-4592, Healthy Subjects
- What is being tested?
- FG-4592
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2013to Dec 2013
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- YOUNG: Subject is a healthy young male or a healthy female subject aged 18 to 45 years of age inclusive
- ELDERLY: Subject is a healthy elderly male or female subject aged 65 or above
- Male subject and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of 2 forms of birth control
- Male subject must not donate sperm starting at screening and throughout the study period and for 90 days after the final study drug administration
- Female subject must be either of non-childbearing potential or, if of childbearing potential, must have a negative pregnancy test at screening and Day -2 and must use 2 forms of birth control
- Female subject must not be breastfeeding at screening or during the study period and for 28 days after the final study drug administration
- Female subject must not donate ova starting at screening and throughout the study period and for 28 days after the final study drug administration
Who cannot join
- Female subject who has been pregnant within 6 months before screening or breastfeeding within 3 months before screening
- Subject used grapefruit, grapefruit juice (more than 3 x 200 mL) or orange marmalade (more than 3 times) in the week prior to admission to the clinic until ESV
- The subject is a vulnerable subject
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Double-blind, Randomized, Placebo-controlled, 4-way Crossover Study to Evaluate the Dose-proportionality and Pharmacokinetics of FG-4592 in Healthy Young and Elderly Male and Female Subjects
This study evaluates the concentration of FG-4592 in the blood over a certain period after the intake of different doses, and assesses the effects, the safety and the tolerability of the study drug in healthy young and elderly male and female subjects.
On Day 1 of each of 4 periods subjects receive different single doses of FG-4592 or a placebo, depending on the treatment sequence to which they are randomized. For each period the subjects remain in the clinic for 6 days (Days -2 to 4). They are discharged after all assessments are completed on Day 4 of each period, and return for an End of Study visit (ESV) between 5 and 9 days after the last assessment of Period 4.
Read the detailed description
In this study eligible subjects reside in the clinic for 4 periods of 6 days (Day -2 through Day 4). Screening takes place from Day -23 through Day -3. Subjects are admitted to the clinic on Day -2 of Period 1. Within each cohort (young and elderly subjects), subjects are randomized to one of 24 treatment sequences of 4 treatment options (3 different doses of FG-4592 and placebo) and 4 periods.
On Day 1 of each period, subjects receive a single oral dose of FG-4592 or placebo followed by a 72-hour evaluation period. Subjects are discharged on Day 4, if there are no medical reasons for a prolonged stay. Each period is separated by a wash-out period of at least 10 days between dosing on Day 1 of the previous period and dosing on Day 1 of the following period. The subjects return for an end-of-study visit (ESV) 5-9 days after the last assessment of Period 4 (or after early withdrawal).
Plasma and urine samples are collected for pharmacokinetic (PK) and pharmacodynamic (PD) assessments. Safety assessments are performed throughout the study.
- Conditions
- PK for FG-4592, Healthy Subjects
- Being tested
- FG-4592, Placebo
- Keywords
- Phase 1, FG-4592, Age/gender comparison
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FG-4592Drug
Also called ASP1517,, roxadustat
Oral
PlaceboDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| 1: young male subjects | Experimental | 3x single dose of FG-4592 and a placebo Receives: Drug: FG-4592; Drug: Placebo |
| 2: young female subjects | Experimental | 3x single dose of FG-4592 and a placebo Receives: Drug: FG-4592; Drug: Placebo |
| 3: elderly male subjects | Experimental | 3x single dose of FG-4592 and a placebo Receives: Drug: FG-4592; Drug: Placebo |
| 4: elderly female subjects | Experimental | 3x single dose of FG-4592 and a placebo Receives: Drug: FG-4592; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK after a single dose of FG-4592 measured by area under the concentration-time curve from the time of dosing extrapolated to time infinity (AUCinf),
Measured: Days 1- 4 (all periods)
PK after a single dose of FG-4592 measured by maximum concentration (Cmax)
Measured: Days 1- 4 (all periods)
Secondary outcomes (4)
PK of FG-4592 in plasma
area under the concentration-time curve (AUC) from time point 0 to time point 24 hours (AUC0-24h), unbound AUC from time point 0 to time point 24 hours (AUC0-24h,u), AUC from the time of dosing to the last measurable concentration (Clast) (AUClast), unbound AUC from the time of dosing to Clast (AUClast,u), unbound AUC extrapolated to infinity (AUCinf,u), maximum unbound plasma concentration (Cmax,u), apparent total body clearance after extra-vascular dosing (CL/F), unbound CL/F (CLu/F), fraction unbound (fu), time interval between the time of dosing and the first measurable concentration above LOQ in Plasma (tlag), time of the maximum concentration (tmax), terminal elimination half-life (t1/2), apparent volume of distribution during the terminal elimination phase after single extravascular dosing (Vz/F), unbound Vz/F (Vz,u/F)
Measured: Days 1 - 4 (all periods)
PK of FG-4592 in urine
renal clearance (CLR), unbound CLR (CLR,u), CLR from time point 0 to 24 hours (CLR,0-24h), unbound CLR,0-24h (CLR,0-24h,u), cumulative amount of drug excreted unchanged into urine, from time of dosing extrapolated to time infinity (Aeinf), percent of drug excreted unchanged into urine from time of dosing extrapolated to time infinity in percent of dose (Aeinf%), cumulative amount of drug excreted unchanged into urine, from time of dosing up to the collection time of the last measurable concentration (Aelast), percent of drug excreted into urine (Aelast) from time of dosing up to the collection time of the last measurable concentration in percent of dose (Aelast%), cumulative amount of drug excreted unchanged into urine, from time of dosing up to the collection time of 24 hours (Ae0-24h), Ae0-24h in percent of dose (Ae0-24h%)
Measured: Days 1 - 4 (all periods)
Plasma concentration of EPO, VEGF, reticulocytes and hepcidin
EPO(erythropoietin), VEGF(vascular endothelial growth factor)
Measured: Days 1 - 4 (all periods)
Safety and tolerability of a single dose FG-4592
AEs, resting vital signs, safety laboratory tests, 12-lead safety ECG, mean heart rate per hour for 24-hours
Measured: Screening to ESV (5-9 days after the last assessment of Period 4 (or after early withdrawal))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2014 (estimated)
- Study startSep 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PK for FG-4592Studies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kyntra Bio
- Responsible party
- Sponsor
- Investigators
- Central Contact, Study director, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02161796
- Sponsor's protocol ID
- 1517-CL-0525
- Other IDs
- 2013-001044-57
- Status last verified
- Jun 2014
- First submitted
- 10 Jun 2014
- Last updated
- 12 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-blind, Randomized, Placebo-controlled, 4-way Crossover Study to Evaluate the Dose-proportionality and Pharmacokinetics of FG-4592 in Healthy Young and Elderly Male and Female Subjects
- ClinicalTrials.gov ID
- NCT02161796
- Acronym / sponsor ID
- 1517-CL-0525
- Conditions
- PK for FG-4592, Healthy Subjects
- Keywords
- Phase 1, FG-4592, Age/gender comparison
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Astellas Pharma Europe B.V.Industry (pharma, biotech, devices)
- Collaborators
- Kyntra Bio
- Study start
- Sep 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 12 Jun 2014 (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 study evaluates the concentration of FG-4592 in the blood over a certain period after the intake of different doses, and assesses the effects, the safety and the tolerability of the study drug in healthy young and elderly male and female subjects.
On Day 1 of each of 4 periods subjects receive different single doses of FG-4592 or a placebo, depending on the treatment sequence to which they are randomized. For each period the subjects remain in the clinic for 6 days (Days -2 to 4). They are discharged after all assessments are completed on Day 4 of each period, and return for an End of Study visit (ESV) between 5 and 9 days after the last assessment of Period 4.
Detailed description
In this study eligible subjects reside in the clinic for 4 periods of 6 days (Day -2 through Day 4). Screening takes place from Day -23 through Day -3. Subjects are admitted to the clinic on Day -2 of Period 1. Within each cohort (young and elderly subjects), subjects are randomized to one of 24 treatment sequences of 4 treatment options (3 different doses of FG-4592 and placebo) and 4 periods.
On Day 1 of each period, subjects receive a single oral dose of FG-4592 or placebo followed by a 72-hour evaluation period. Subjects are discharged on Day 4, if there are no medical reasons for a prolonged stay. Each period is separated by a wash-out period of at least 10 days between dosing on Day 1 of the previous period and dosing on Day 1 of the following period. The subjects return for an end-of-study visit (ESV) 5-9 days after the last assessment of Period 4 (or after early withdrawal).
Plasma and urine samples are collected for pharmacokinetic (PK) and pharmacodynamic (PD) assessments. Safety assessments are performed throughout the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1: young male subjects | Experimental | Drug: FG-4592, Drug: Placebo3x single dose of FG-4592 and a placebo |
| 2: young female subjects | Experimental | Drug: FG-4592, Drug: Placebo3x single dose of FG-4592 and a placebo |
| 3: elderly male subjects | Experimental | Drug: FG-4592, Drug: Placebo3x single dose of FG-4592 and a placebo |
| 4: elderly female subjects | Experimental | Drug: FG-4592, Drug: Placebo3x single dose of FG-4592 and a placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- YOUNG: Subject is a healthy young male or a healthy female subject aged 18 to 45 years of age inclusive
- ELDERLY: Subject is a healthy elderly male or female subject aged 65 or above
- Male subject and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of 2 forms of birth control
- Male subject must not donate sperm starting at screening and throughout the study period and for 90 days after the final study drug administration
- Female subject must be either of non-childbearing potential or, if of childbearing potential, must have a negative pregnancy test at screening and Day -2 and must use 2 forms of birth control
Key exclusion criteria (3 listed)
- Female subject who has been pregnant within 6 months before screening or breastfeeding within 3 months before screening
- Subject used grapefruit, grapefruit juice (more than 3 x 200 mL) or orange marmalade (more than 3 times) in the week prior to admission to the clinic until ESV
- The subject is a vulnerable subject
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 |
|---|---|---|
| FG-4592Also: ASP1517,, roxadustatOral | Drug | 1: young male subjects, 2: young female subjects, 3: elderly male subjects, 4: elderly female subjects |
| PlaceboOral | Drug | 1: young male subjects, 2: young female subjects, 3: elderly male subjects, 4: elderly female subjects |
Primary outcome
PK after a single dose of FG-4592 measured by area under the concentration-time curve from the time of dosing extrapolated to time infinity (AUCinf),
Time frame: Days 1- 4 (all periods)
PK after a single dose of FG-4592 measured by maximum concentration (Cmax)
Time frame: Days 1- 4 (all periods)
4 secondary outcomes
PK of FG-4592 in plasma
Time frame: Days 1 - 4 (all periods)
PK of FG-4592 in urine
Time frame: Days 1 - 4 (all periods)
Plasma concentration of EPO, VEGF, reticulocytes and hepcidin
Time frame: Days 1 - 4 (all periods)
Safety and tolerability of a single dose FG-4592
Time frame: Screening to ESV (5-9 days after the last assessment of Period 4 (or after early withdrawal))
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 12 Jun 2014.
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.
Central Contact study director
Astellas Pharma Europe B.V.
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 FG-4592 in people with PK for FG-4592 and Healthy Subjects, run by Astellas Pharma Europe B.V. at 1 site in Germany.
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 7 inclusion and 3 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 12 Jun 2014. 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 Germany. 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?
PK after a single dose of FG-4592 measured by area under the concentration-time curve from the time of dosing extrapolated to time infinity (AUCinf), (time frame: Days 1- 4 (all periods)). 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 12 Jun 2014.