HealthyPhase 1NCT01675518
A Study to Assess the Safety, Pharmacological Effect and Plasma Concentration of ASP7991 After Single Oral Administration to Healthy Volunteers
A Phase 1 study testing ASP7991 in people with Healthy and Pharmacokinetics of ASP7991, run by Astellas Pharma Inc at 1 site in Japan.
Trial summary
This study is to assess the safety, tolerability, plasma concentration and pharmacodynamics of ASP7991 after single oral administration to healthy volunteers. In part-1, ASP7991 is administered in a dose escalation design. In part-2, plasma concentration changes of ASP7991 in fasted and fed conditions are compared. Read more about this study
- Who is it for?
- Ages 20 to 44 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Pharmacokinetics of ASP7991
- What is being tested?
- ASP7991
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2012to Jun 2012
- 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 44 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, as judged by the investigator/sub investigator based on the results of physical examination obtained before study drug administration
- Body weight: ≥50.0 kg, <80.0 kg
- BMI: ≥17.6, <26.4
- Serum corrected calcium concentration: ≥9.0mg/dL, <10.4 mg/dL
Who cannot join
- Received any investigational drugs in other clinical or post-marketing studies within 120 days before screening
- Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before screening
- Received medication (including marketed drug) within 7 days before hospitalization, vitamin preparation including vitamin D and supplement including calcium or is scheduled to receive medication
- A deviation from normal criteria range of 12-lead ECG (QT evaluation)
- A deviation from the normal range in clinical laboratory tests
- Highly sensitive cardiac troponin T (at screening): ≥0.014 ng/mL
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- History of drug allergies
- Upper gastrointestinal disease (e.g. nausea, vomiting, stomachache) within 7 days before admission
- Concurrent or previous hepatic disease (e.g., viral hepatitis, drug-induced liver injury)
- Concurrent or previous endocrine disorders (e.g.,hyperthyroidism, aberration in growth hormone)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of a Single Oral Administration of ASP7991 in Healthy Volunteers
This study is to assess the safety, tolerability, plasma concentration and pharmacodynamics of ASP7991 after single oral administration to healthy volunteers. In part-1, ASP7991 is administered in a dose escalation design. In part-2, plasma concentration changes of ASP7991 in fasted and fed conditions are compared.
Read the detailed description
This study consists of two parts. In Part 1, the study will begin as a single rising dose escalation design under randomized double-blind and fasting conditions. In each dose group, volunteers will be randomized to receive an oral administration of either active drug (ASP7991) or placebo. The dose escalation will be determined after blinded safety assessment.
Part 2 is a study to evaluate the effect of food intake. ASP7991 will be administered to volunteers under 2 conditions, fasting and fed, on 2-way crossover method.
- Conditions
- Healthy, Pharmacokinetics of ASP7991
- Being tested
- ASP7991, Placebo
- Keywords
- Plasma concentration, ASP7991, food effect, PTH (parathyroid hormone)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP7991Drug
oral
PlaceboDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| Part-1 dose 1 | Experimental | Not described Receives: Drug: ASP7991 |
| Part-1 dose 2 | Experimental | Not described Receives: Drug: ASP7991 |
| Part-1 dose 3 | Experimental | Not described Receives: Drug: ASP7991 |
| Part-1 dose 4 | Experimental | Not described Receives: Drug: ASP7991 |
| Part-1 dose 5 | Experimental | Not described Receives: Drug: ASP7991 |
| Part-1 dose 6 | Experimental | Not described Receives: Drug: ASP7991 |
| Part-1 placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Part-2 fed | Experimental | Not described Receives: Drug: ASP7991 |
| Part-2 fasted | Experimental | Not described Receives: Drug: ASP7991 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety of ASP7991 assessed by the incidence of adverse events, vital signs, laboratory tests, 12-lead ECGs and Holter ECGs
Measured: for 96 hours after dosing
Secondary outcomes (3)
Plasma Concentration of unchanged drug :Cmax, tmax, AUClast, AUCinf, t1/2, CL/F
Blood samples are collected at the following times: redose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12,16, 24, 48, 72 and 96 hours
Measured: for 96 hours after dosing
Urinary concentrations of unchanged drug: Aelast，Aelast%, CLr
Urine samples are collected at the following times: redose and 0-4, 4-8, 8-12, 12-24, 24-36, 36-48, 48-72, 72-96 hours
Measured: for 96 hour after dosing
plasma parathyroid hormon concentration
Blood samples are collected at the following times: redose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12,16, 24, 48, 72 and 96 hours
Measured: for 96 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2012 (estimated)
- Study startJan 2012
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01675518
- Sponsor's protocol ID
- 7991-CL-0001
- Status last verified
- Aug 2012
- First submitted
- 28 Aug 2012
- Last updated
- 30 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of a Single Oral Administration of ASP7991 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01675518
- Acronym / sponsor ID
- 7991-CL-0001
- Conditions
- Healthy, Pharmacokinetics of ASP7991
- Keywords
- Plasma concentration, ASP7991, food effect, PTH (parathyroid hormone)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 30 Aug 2012 (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 is to assess the safety, tolerability, plasma concentration and pharmacodynamics of ASP7991 after single oral administration to healthy volunteers. In part-1, ASP7991 is administered in a dose escalation design. In part-2, plasma concentration changes of ASP7991 in fasted and fed conditions are compared.
Detailed description
This study consists of two parts. In Part 1, the study will begin as a single rising dose escalation design under randomized double-blind and fasting conditions. In each dose group, volunteers will be randomized to receive an oral administration of either active drug (ASP7991) or placebo. The dose escalation will be determined after blinded safety assessment.
Part 2 is a study to evaluate the effect of food intake. ASP7991 will be administered to volunteers under 2 conditions, fasting and fed, on 2-way crossover method.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Part-1 dose 1 | Experimental | Drug: ASP7991 |
| Part-1 dose 2 | Experimental | Drug: ASP7991 |
| Part-1 dose 3 | Experimental | Drug: ASP7991 |
| Part-1 dose 4 | Experimental | Drug: ASP7991 |
| Part-1 dose 5 | Experimental | Drug: ASP7991 |
| Part-1 dose 6 | Experimental | Drug: ASP7991 |
| Part-1 placebo | Placebo comparator | Drug: Placebo |
| Part-2 fed | Experimental | Drug: ASP7991 |
| Part-2 fasted | Experimental | Drug: ASP7991 |
Who may qualify
- Ages
- 20 to 44 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy, as judged by the investigator/sub investigator based on the results of physical examination obtained before study drug administration
- Body weight: ≥50.0 kg, <80.0 kg
- BMI: ≥17.6, <26.4
- Serum corrected calcium concentration: ≥9.0mg/dL, <10.4 mg/dL
Key exclusion criteria (10 listed)
- Received any investigational drugs in other clinical or post-marketing studies within 120 days before screening
- Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before screening
- Received medication (including marketed drug) within 7 days before hospitalization, vitamin preparation including vitamin D and supplement including calcium or is scheduled to receive medication
- A deviation from normal criteria range of 12-lead ECG (QT evaluation)
- A deviation from the normal range in clinical laboratory tests
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 |
|---|---|---|
| ASP7991oral | Drug | Part-1 dose 1, Part-1 dose 2, Part-1 dose 3, Part-1 dose 4, Part-1 dose 5, Part-1 dose 6, Part-2 fasted, Part-2 fed |
| Placebooral | Drug | Part-1 placebo |
Primary outcome
The safety of ASP7991 assessed by the incidence of adverse events, vital signs, laboratory tests, 12-lead ECGs and Holter ECGs
Time frame: for 96 hours after dosing
3 secondary outcomes
Plasma Concentration of unchanged drug :Cmax, tmax, AUClast, AUCinf, t1/2, CL/F
Time frame: for 96 hours after dosing
Urinary concentrations of unchanged drug: Aelast，Aelast%, CLr
Time frame: for 96 hour after dosing
plasma parathyroid hormon concentration
Time frame: for 96 hours after dosing
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 30 Aug 2012.
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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.
Medical Director study director
Astellas Pharma 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 ASP7991 in people with Healthy and Pharmacokinetics of ASP7991, run by Astellas Pharma Inc 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 4 inclusion and 10 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 30 Aug 2012. 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. Some participants in this study may receive a placebo. 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?
The safety of ASP7991 assessed by the incidence of adverse events, vital signs, laboratory tests, 12-lead ECGs and Holter ECGs (time frame: for 96 hours after dosing). 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 30 Aug 2012.