Healthy Adult SubjectsPhase 1NCT03960489
A Study to Assess the Relative Bioavailability of Roxadustat Following a Single Dose of Pediatric Azo Dye-free Tablet Formulation and Pediatric Azo Dye-free Mini-tablet Formulation Compared to a Single Dose of Azo Dye-containing Tablet Formulation in Healthy Adult Subjects
A Phase 1 study testing Roxadustat in people with Healthy Adult Subjects, run by Astellas Pharma Global Development, Inc. at 1 site in Germany.
Trial summary
The purpose of the study is to assess the relative bioavailability of single doses of 100 mg roxadustat pediatric azo dye-free tablet and 100 mg roxadustat pediatric azo dye-free mini-tablet solid and suspension (new formulations) compared to 100 mg roxadustat azo dye-containing tablet (reference formulation) under… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Subjects
- What is being tested?
- Roxadustat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- 31 Jul 2019to 14 Oct 2019
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject has a body mass index range of 18.5 to 30.0 kg/m2, inclusive and weighs at least 50 kg at screening.
- A female subject is eligible to participate if she is not pregnant and at least 1 of the following conditions applies:
- Not a woman of childbearing potential (WOCBP), or
- WOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for at least 28 days after the final study drug administration.
- Female subject must agree not to breastfeed starting at screening and throughout 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.
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- A male subject with female partner(s) of childbearing potential must agree to use contraception during the treatment period and for at least 28 days after the final study drug administration.
- A male subject must not donate sperm during the treatment period and for at least 28 days after the final study drug administration.
- Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner(s) is (are) breastfeeding throughout the study period and for 28 days after the final study drug administration.
- Subject agrees not to participate in another interventional study while participating in the present study.
Who cannot join
- Subject has received any investigational study drug within 28 days or 5 half lives, whichever is longer, prior to screening.
- Subject has any condition which makes the subject unsuitable for study participation.
- Female subject who has been pregnant within 6 months prior to screening assessment or breastfeeding within 3 months prior to screening.
- Subject has a known or suspected hypersensitivity to roxadustat or any components of the formulation used.
- Subject has had previous exposure with roxadustat.
- Subject has any of the liver function tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase, gamma-glutamyl transferase and total bilirubin [TBL]) above the upper limit of normal (ULN) on day -1. In such a case, the assessment may be repeated once.
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- Subject has any clinically significant history of allergic conditions (including drug allergies, asthma, eczema, or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies) prior to study drug administration.
- Subject has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy.
- Subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (noncutaneous) infection within 1 week prior to day -1.
- Subject has any clinically significant abnormality of the physical examination, electrocardiogram (ECG) and protocol-defined clinical laboratory tests at screening or on day -1.
- Subject has a mean pulse < 50 or > 90 bpm; mean systolic blood pressure > 140 mmHg; mean diastolic blood pressure > 90 mmHg (measurements taken in triplicate after subject has been resting in supine position for 5 minutes; pulse will be measured automatically) on day -1. If the mean blood pressure exceeds the limits above, 1 additional measurement in triplicate can be taken.
- Subject has a mean corrected QT interval using Fridericia's formula (QTcF) of > 430 msec (for male subjects) and > 450 msec (for female subjects) on day -1. If the mean QTcF exceeds the limits above, 1 additional triplicate ECG can be taken.
- Subject has used any prescribed or nonprescribed drugs (including vitamins, calcium and iron supplements, natural and herbal remedies, e.g., St. John's Wort) in the 2 weeks prior to study drug administration, except for occasional use of paracetamol (up to 2 g/day), topical dermatological products, including corticosteroid products, hormonal contraceptives and hormone replacement therapy.
- Subject has smoked or has used tobacco-containing products and nicotine or nicotine-containing products in the past 6 months prior to screening.
- Subject has a history of drinking more than 24 g/day of alcohol (10 g pure alcohol = 250 mL of beer [5%] or 35 mL of spirits [35%] or 100 mL of wine [12%]) (> 12 g/day of alcohol for female subjects) within 3 months prior to day -1 or the subject tests positive for alcohol or drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and opiates) at screening or on day -1.
- Subject has used any drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and opiates) within 3 months prior to day -1.
- Subject has used any inducer of metabolism (e.g., barbiturates and rifampin) in the 3 months prior to day -1.
- Subject has consumed grapefruit, Seville oranges, grapefruit-containing products or Seville orange-containing products within 72 hours prior to day -1.
- Subject has had significant blood loss, donated 1 unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to day -1.
- Subject has a positive serology test for hepatitis B surface antigen, hepatitis B core antibodies, hepatitis A virus antibodies (immunoglobulin M), hepatitis C virus antibodies or antibodies to human immunodeficiency virus type 1 and/or type 2 at screening.
- Subject is an employee of Astellas or the clinical site.
- Subject is a vulnerable subject (e.g., subject kept in detention, protected adult under guardianship/trusteeship, soldier or committed to an institution by governmental or juridical order).
- Subject has abnormal renal function, indicated by creatinine above the ULN or chronic kidney disease epidemiology collaboration based estimated glomerular filtration rate (eGFR) < 90 mL/min on day 1. In such a case, the assessment may be repeated once.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Crossover Study to Assess the Relative Bioavailability of Roxadustat Following a Single Dose of Pediatric Azo Dye-free Tablet and Pediatric Azo Dye-free Mini-tablet (Solid and Suspension) Compared to a Single Dose of Azo Dye-containing Tablet in Healthy Adult Subjects
The purpose of the study is to assess the relative bioavailability of single doses of 100 mg roxadustat pediatric azo dye-free tablet and 100 mg roxadustat pediatric azo dye-free mini-tablet solid and suspension (new formulations) compared to 100 mg roxadustat azo dye-containing tablet (reference formulation) under fasting conditions in healthy male and female adult participants.
This study will also evaluate the safety and tolerability of single doses of 100 mg roxadustat pediatric azo dye-free tablet and 100 mg roxadustat pediatric azo dye-free mini-tablet solid and suspension (new formulations) and a single dose of 100 mg roxadustat azo dye-containing tablet (reference formulation) under fasting conditions in healthy male and female adult participants.
Read the detailed description
This is a 4-period, 4-sequence single dose crossover study. Each participant will participate in 4 treatment periods separated by a washout of at least 7 days between study drug administrations in each period. Participants will be randomized to 1 of 4 sequences.
Participants will be screened for up to 21 days prior to study drug administration on day 1 of period 1. Eligible participants will be admitted to the clinical unit on day -1 of each period and will be residential for 5 days/4 nights.
Participants will receive a single dose of 100 mg roxadustat pediatric azo dye-free tablet, 100 mg roxadustat pediatric azo dye-free mini-tablet (suspension), 100 mg roxadustat pediatric azo dye-free mini-tablet (solid) (new formulations) or 100 mg roxadustat azo dye-containing tablet (reference formulation) under fasting conditions on day 1 of each period.
- Conditions
- Healthy Adult Subjects
- Being tested
- Roxadustat
- Keywords
- Pharmacokinetics, Tolerability, Safety, ASP1517, Roxadustat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RoxadustatDrug
Also called ASP1517
Participants will receive single dose of 100 mg azo dye free tablet or mini tablet suspension or solid mini tablet or dye containing tablet.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Sequence 1 (ABCD) | Experimental | Participants will receive single dose of 100 mg roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 1 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 2 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 3 followed by 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 4. Each period will be of 6 days. A washout period of 7 days will be included between each period. Receives: Drug: Roxadustat |
| Treatment Sequence 2 (BDAC) | Experimental | Participants will receive 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 1 followed by single dose of 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 2 followed by 100 mg roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 3 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 4. Each period will be of 6 days. A washout period of 7 days will be included between each period. Receives: Drug: Roxadustat |
| Treatment Sequence 3 (CADB) | Experimental | Participants will receive single dose of 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 1 followed by 100 mg roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 2 followed by 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 3 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 4. Each period will be of 6 days. A washout period of 7 days will be included between each period. Receives: Drug: Roxadustat |
| Treatment Sequence 4 (DCBA) | Experimental | Participants will receive single dose of 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 1 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 2 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 3 followed by 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 4. Each period will be of 6 days. A washout period of 7 days will be included between each period. Receives: Drug: Roxadustat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve From Time of Dosing Extrapolated to Time Infinity (AUCinf) for Roxadustat
AUCinf is defined as area under the plasma concentration versus time curve from time of dosing (pre-dose) to extrapolated infinite time (0-inf).
Measured: Predose (0 hour), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose on day 1
Area Under the Concentration-Time Curve From the Time of Dosing to Last Measurable Concentration (AUClast) for Roxadustat
AUClast is defined as area under the plasma concentration time-curve from time of dosing to the last measured concentration.
Measured: Predose (0 hour), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose on day 1
Pharmacokinetics (PK) of Maximum Observed Concentration of Roxadustat
Maximum observed concentration (Cmax) will be reported.
Measured: Predose (0 hour), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose on day 1
Secondary outcomes (7)
Percentage of the Area Under the Concentration-Time Curve From the Time of Dosing to Time infinity due to Extrapolation From the Last Measurable Concentration to Time Infinity (AUCinf[%extrap]) for Roxadustat
AUC%extrap is defined as the percentage of AUC [0-∞] obtained by forward extrapolation. It will be calculated as (AUC [0-∞] minus AUClast)*100/ AUC [0-∞], where AUC [0-∞] = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-∞) and AUClast is area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration.
Measured: Predose (0 hour), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose on day 1
Apparent Total Systemic Clearance of Roxadustat After Extravascular Dosing (CL/F)
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
Measured: Predose (0 hour), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose on day 1
Terminal Elimination Half-life (t1/2) of Roxadustat
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Measured: Predose (0 hour), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose on day 1
Time to Reach Maximum Concentration (tmax) of Roxadustat
Time to reach maximum concentration of roxadustat following drug administration will be reported.
Measured: Predose (0 hour), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose on day 1
Time Prior to the Time Corresponding to the First Measurable (nonzero) Concentration (tlag) of Roxadustat
Tlag is defined as the time prior to the time corresponding to the first measurable concentration.
Measured: Predose (0 hour), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose on day 1
Apparent Volume of Distribution During the Terminal Elimination Phase After Extravascular Dosing (Vz/F) of Roxadustat
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Measured: Predose (0 hour), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose on day 1
Number of Participants With Treatment-Emergent Adverse Event (TEAEs)
An AE is defined as any untoward medical occurrence in a participant who will be given the study drug or who has undergone study procedures and did not necessarily has a causal relationship with this treatment. An AE could therefore be any unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A treatment-emergent adverse event is defined as an adverse event with onset at any time from dosing until the last scheduled procedure.
Measured: From first dose of study drug up to end of study visit (up to 54 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start31 Jul 2019
- Primary completion14 Oct 2019
- Study completion14 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult SubjectsStudies of the same condition, open and under way.
- More trials run by Astellas Pharma Global Development, Inc.The 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kyntra Bio
- Responsible party
- Sponsor
- Investigators
- Senior Medical Director, Study director, Astellas Pharma Global Development, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03960489
- Sponsor's protocol ID
- 1517-CL-1001
- Other IDs
- 2018-002924-18, 2018
- Status last verified
- Oct 2024
- First submitted
- 21 May 2019
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Crossover Study to Assess the Relative Bioavailability of Roxadustat Following a Single Dose of Pediatric Azo Dye-free Tablet and Pediatric Azo Dye-free Mini-tablet (Solid and Suspension) Compared to a Single Dose of Azo Dye-containing Tablet in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT03960489
- Acronym / sponsor ID
- 1517-CL-1001
- Conditions
- Healthy Adult Subjects
- Keywords
- Pharmacokinetics, Tolerability, Safety, ASP1517, Roxadustat
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Kyntra Bio
- Study start
- 31 Jul 2019 (actual)
- Primary completion
- 14 Oct 2019 (actual)
- Study completion
- 14 Oct 2019 (actual)
- First posted
- 23 May 2019 (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 the study is to assess the relative bioavailability of single doses of 100 mg roxadustat pediatric azo dye-free tablet and 100 mg roxadustat pediatric azo dye-free mini-tablet solid and suspension (new formulations) compared to 100 mg roxadustat azo dye-containing tablet (reference formulation) under fasting conditions in healthy male and female adult participants.
This study will also evaluate the safety and tolerability of single doses of 100 mg roxadustat pediatric azo dye-free tablet and 100 mg roxadustat pediatric azo dye-free mini-tablet solid and suspension (new formulations) and a single dose of 100 mg roxadustat azo dye-containing tablet (reference formulation) under fasting conditions in healthy male and female adult participants.
Detailed description
This is a 4-period, 4-sequence single dose crossover study. Each participant will participate in 4 treatment periods separated by a washout of at least 7 days between study drug administrations in each period. Participants will be randomized to 1 of 4 sequences.
Participants will be screened for up to 21 days prior to study drug administration on day 1 of period 1. Eligible participants will be admitted to the clinical unit on day -1 of each period and will be residential for 5 days/4 nights.
Participants will receive a single dose of 100 mg roxadustat pediatric azo dye-free tablet, 100 mg roxadustat pediatric azo dye-free mini-tablet (suspension), 100 mg roxadustat pediatric azo dye-free mini-tablet (solid) (new formulations) or 100 mg roxadustat azo dye-containing tablet (reference formulation) under fasting conditions on day 1 of each period.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence 1 (ABCD) | Experimental | Drug: RoxadustatParticipants will receive single dose of 100 mg roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 1 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 2 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 3 followed by 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 4. Each period will be of 6 days. A washout period of 7 days will be included between each period. |
| Treatment Sequence 2 (BDAC) | Experimental | Drug: RoxadustatParticipants will receive 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 1 followed by single dose of 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 2 followed by 100 mg roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 3 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 4. Each period will be of 6 days. A washout period of 7 days will be included between each period. |
| Treatment Sequence 3 (CADB) | Experimental | Drug: RoxadustatParticipants will receive single dose of 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 1 followed by 100 mg roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 2 followed by 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 3 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 4. Each period will be of 6 days. A washout period of 7 days will be included between each period. |
| Treatment Sequence 4 (DCBA) | Experimental | Drug: RoxadustatParticipants will receive single dose of 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 1 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 2 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 3 followed by 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 4. Each period will be of 6 days. A washout period of 7 days will be included between each period. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Subject has a body mass index range of 18.5 to 30.0 kg/m2, inclusive and weighs at least 50 kg at screening.
- A female subject is eligible to participate if she is not pregnant and at least 1 of the following conditions applies:
- Female subject must agree not to breastfeed starting at screening and throughout 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.
- A male subject with female partner(s) of childbearing potential must agree to use contraception during the treatment period and for at least 28 days after the final study drug administration.
Key exclusion criteria (23 listed)
- Subject has received any investigational study drug within 28 days or 5 half lives, whichever is longer, prior to screening.
- Subject has any condition which makes the subject unsuitable for study participation.
- Female subject who has been pregnant within 6 months prior to screening assessment or breastfeeding within 3 months prior to screening.
- Subject has a known or suspected hypersensitivity to roxadustat or any components of the formulation used.
- Subject has had previous exposure with roxadustat.
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 |
|---|---|---|
| RoxadustatAlso: ASP1517Participants will receive single dose of 100 mg azo dye free tablet or mini tablet suspension or solid mini tablet or dye containing tablet. | Drug | Treatment Sequence 1 (ABCD), Treatment Sequence 2 (BDAC), Treatment Sequence 3 (CADB), Treatment Sequence 4 (DCBA) |
Primary outcome
Area Under the Curve From Time of Dosing Extrapolated to Time Infinity (AUCinf) for Roxadustat
Time frame: Predose (0 hour), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose on day 1
AUCinf is defined as area under the plasma concentration versus time curve from time of dosing (pre-dose) to extrapolated infinite time (0-inf).
Area Under the Concentration-Time Curve From the Time of Dosing to Last Measurable Concentration (AUClast) for Roxadustat
Time frame: Predose (0 hour), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose on day 1
AUClast is defined as area under the plasma concentration time-curve from time of dosing to the last measured concentration.
Pharmacokinetics (PK) of Maximum Observed Concentration of Roxadustat
Time frame: Predose (0 hour), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose on day 1
Maximum observed concentration (Cmax) will be reported.
7 secondary outcomes
Percentage of the Area Under the Concentration-Time Curve From the Time of Dosing to Time infinity due to Extrapolation From the Last Measurable Concentration to Time Infinity (AUCinf[%extrap]) for Roxadustat
Time frame: Predose (0 hour), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose on day 1
Apparent Total Systemic Clearance of Roxadustat After Extravascular Dosing (CL/F)
Time frame: Predose (0 hour), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose on day 1
Terminal Elimination Half-life (t1/2) of Roxadustat
Time frame: Predose (0 hour), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose on day 1
Time to Reach Maximum Concentration (tmax) of Roxadustat
Time frame: Predose (0 hour), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose on day 1
Time Prior to the Time Corresponding to the First Measurable (nonzero) Concentration (tlag) of Roxadustat
Time frame: Predose (0 hour), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose on day 1
Apparent Volume of Distribution During the Terminal Elimination Phase After Extravascular Dosing (Vz/F) of Roxadustat
Time frame: Predose (0 hour), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose on day 1
Number of Participants With Treatment-Emergent Adverse Event (TEAEs)
Time frame: From first dose of study drug up to end of study visit (up to 54 days)
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 31 Oct 2024.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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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.
Senior Medical Director study director
Astellas Pharma Global Development, Inc.
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 Roxadustat in people with Healthy Adult Subjects, run by Astellas Pharma Global Development, Inc. 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 10 inclusion and 23 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 31 Oct 2024. 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?
Area Under the Curve From Time of Dosing Extrapolated to Time Infinity (AUCinf) for Roxadustat (time frame: Predose (0 hour), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose on day 1). The study lists 3 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 31 Oct 2024.