Clinical PharmacologyPhase 1NCT03074058
Bioequivalence Study of BAY 77-1931 Orally Disintegrating Tablet
A Phase 1 study testing Fosrenol ODT (Lanthanum Carbonate, BAY77-1931) and Fosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931) in people with Clinical Pharmacology, run by Bayer at 1 site in Japan.
Trial summary
The primary objective of this study was to establish the bioequivalence of two different tablet formulations containing BAY77-1931. The secondary objectives of this study were to assess the safety and tolerability, as well as to Investigate the plasma lanthanum concentration after BAY 77-1931 ODT 500 mg administration. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Clinical Pharmacology
- What is being tested?
- Fosrenol ODT (Lanthanum Carbonate, BAY77-1931) and Fosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteJapan
- Study dates
- 10 Jun 2015to 21 Aug 2015
- 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Japanese healthy male adult volunteers (age, 20-45 years; BMI, 17.6-26.4 kg/m2)
Who cannot join
- Regular use of medicines including Chinese herbal drugs
- Clinically relevant findings in the physical examination
- Subject who cannot take the study drug appropriately (e.g. weak biting force, insufficient salivary flow)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bioequivalence Study of BAY 77-1931 Orally Disintegrating Tablet - Randomized, Open-label, Two-way Crossover Study to Establish the Bioequivalence Between BAY 77-1931 Orally Disintegrating Tablet 500 mg and Fosrenol Chewable Tablet 500 mg Administered in Japanese Healthy Male Adult Subjects
The primary objective of this study was to establish the bioequivalence of two different tablet formulations containing BAY77-1931. The secondary objectives of this study were to assess the safety and tolerability, as well as to Investigate the plasma lanthanum concentration after BAY 77-1931 ODT 500 mg administration.
- Conditions
- Clinical Pharmacology
- Being tested
- Fosrenol ODT (Lanthanum Carbonate, BAY77-1931), Fosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fosrenol ODT (Lanthanum Carbonate, BAY77-1931)Drug
Fosrenol orally disintegrating tablet, ODT (Lanthanum Carbonate, BAY77-1931) 500 mg, TID
Fosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931)Drug
Fosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931) 500mg, TID
| Study group | Role | What they receive |
|---|---|---|
| Fosrenol ODT (Lanthanum Carbonate, BAY77-1931) | Experimental | Fosrenol BAY 77-1931 orally disintegrating tablet (ODT) 500 mg in Period 1 (day 1-3) and Fosrenol chewable tablet 500mg in Period 2 (day 4-6). The washout interval between period 1 and 2 will be at least 14 days. Receives: Drug: Fosrenol ODT (Lanthanum Carbonate, BAY77-1931) |
| Fosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931) | Active comparator | Fosrenol BAY77-1931 chewable tablet in Period 1 and Fosrenol BAY 77-1931 ODT 500 mg in Period 2. The washout interval between period 1 and 2 will be at least 14 days. Receives: Drug: Fosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacodynamics: Daily urinary phosphate excretion (mmol) on each day
Each study drug was administered as multiple dose over 4-days under fed conditions with a washout interval of at least 14 days in between. Twenty four hours urine collection were repeated 5 times from morning on Day -2 to that on Day 4.
Measured: 6 days
Bioequivalence: Average of daily urinary phosphate excretion (mmol) over 3-day dosing period
During lanthanum carbonate TID treatment period over 3 days in each period (period 1 = day 1-3; period 2 = day 4-6)
Measured: baseline and over 3-days
Secondary outcomes (9)
Pharmacodynamics: Daily urinary phosphate excretion (mmol) on Day 3
Measured: 1 day
Plasma lanthanum concentrations (ng/mL)
To measure plasma concentration of lanthanum, 6 mL of blood were collected before the breakfast on Day 1, Day 2, Day 3 and Day 4, and at 1, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours after administration on Day 4.
Measured: 6 days
Pharmacokinetics: Cmax,md of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6)
Measured: 6 days
Pharmacokinetics: tmax,md of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6)
Measured: 6 days
Pharmacokinetics: Cmax,md,norm of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6)
Measured: 6 days
Pharmacokinetics: AUC(0-tlast)md,norm of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6)
Measured: 6 days
Pharmacokinetics: t1/2,md of lanthanum in plasmafrom pre-administration (Day 4) to 48 hours after the last administration (Day 6)
Measured: 6 days
Number of adverse events as a measure of safety and tolarability
Measured: From Day 1, the day of the first study drug administration, in period 1 (day 1-3) to follow up, 7-10 days after the last study drug administration in period 2 (day 4 - 6)
Pharmacokinetics: AUC(0-tlast)md of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6)
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study start10 Jun 2015
- Primary completion4 Aug 2015
- Study completion21 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical PharmacologyStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03074058
- Sponsor's protocol ID
- 18060
- Status last verified
- Mar 2017
- First submitted
- 3 Mar 2017
- Last updated
- 21 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study of BAY 77-1931 Orally Disintegrating Tablet - Randomized, Open-label, Two-way Crossover Study to Establish the Bioequivalence Between BAY 77-1931 Orally Disintegrating Tablet 500 mg and Fosrenol Chewable Tablet 500 mg Administered in Japanese Healthy Male Adult Subjects
- ClinicalTrials.gov ID
- NCT03074058
- Acronym / sponsor ID
- 18060
- Conditions
- Clinical Pharmacology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2015 (actual)
- Primary completion
- 4 Aug 2015 (actual)
- Study completion
- 21 Aug 2015 (actual)
- First posted
- 8 Mar 2017 (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 primary objective of this study was to establish the bioequivalence of two different tablet formulations containing BAY77-1931. The secondary objectives of this study were to assess the safety and tolerability, as well as to Investigate the plasma lanthanum concentration after BAY 77-1931 ODT 500 mg administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fosrenol ODT (Lanthanum Carbonate, BAY77-1931) | Experimental | Drug: Fosrenol ODT (Lanthanum Carbonate, BAY77-1931)Fosrenol BAY 77-1931 orally disintegrating tablet (ODT) 500 mg in Period 1 (day 1-3) and Fosrenol chewable tablet 500mg in Period 2 (day 4-6). The washout interval between period 1 and 2 will be at least 14 days. |
| Fosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931) | Active comparator | Drug: Fosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931)Fosrenol BAY77-1931 chewable tablet in Period 1 and Fosrenol BAY 77-1931 ODT 500 mg in Period 2. The washout interval between period 1 and 2 will be at least 14 days. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Japanese healthy male adult volunteers (age, 20-45 years; BMI, 17.6-26.4 kg/m2)
Key exclusion criteria (3 listed)
- Regular use of medicines including Chinese herbal drugs
- Clinically relevant findings in the physical examination
- Subject who cannot take the study drug appropriately (e.g. weak biting force, insufficient salivary flow)
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 |
|---|---|---|
| Fosrenol ODT (Lanthanum Carbonate, BAY77-1931)Fosrenol orally disintegrating tablet, ODT (Lanthanum Carbonate, BAY77-1931) 500 mg, TID | Drug | Fosrenol ODT (Lanthanum Carbonate, BAY77-1931) |
| Fosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931)Fosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931) 500mg, TID | Drug | Fosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931) |
Primary outcome
Pharmacodynamics: Daily urinary phosphate excretion (mmol) on each day
Time frame: 6 days
Each study drug was administered as multiple dose over 4-days under fed conditions with a washout interval of at least 14 days in between. Twenty four hours urine collection were repeated 5 times from morning on Day -2 to that on Day 4.
Bioequivalence: Average of daily urinary phosphate excretion (mmol) over 3-day dosing period
Time frame: baseline and over 3-days
During lanthanum carbonate TID treatment period over 3 days in each period (period 1 = day 1-3; period 2 = day 4-6)
9 secondary outcomes
Pharmacodynamics: Daily urinary phosphate excretion (mmol) on Day 3
Time frame: 1 day
Plasma lanthanum concentrations (ng/mL)
Time frame: 6 days
Pharmacokinetics: Cmax,md of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6)
Time frame: 6 days
Pharmacokinetics: tmax,md of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6)
Time frame: 6 days
Pharmacokinetics: Cmax,md,norm of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6)
Time frame: 6 days
Pharmacokinetics: AUC(0-tlast)md,norm of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6)
Time frame: 6 days
Pharmacokinetics: t1/2,md of lanthanum in plasmafrom pre-administration (Day 4) to 48 hours after the last administration (Day 6)
Time frame: 6 days
Number of adverse events as a measure of safety and tolarability
Time frame: From Day 1, the day of the first study drug administration, in period 1 (day 1-3) to follow up, 7-10 days after the last study drug administration in period 2 (day 4 - 6)
Pharmacokinetics: AUC(0-tlast)md of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6)
Time frame: 6 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 21 Mar 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.
Bayer Study Director study director
Bayer
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 Fosrenol ODT (Lanthanum Carbonate, BAY77-1931) and Fosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931) in people with Clinical Pharmacology, run by Bayer at 1 site in Japan.
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 1 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 21 Mar 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 Japan. 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?
Pharmacodynamics: Daily urinary phosphate excretion (mmol) on each day (time frame: 6 days). 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 21 Mar 2017.