Healthy Adult SubjectsPhase 1NCT01297582
Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-6950 in Healthy Adult Subjects
A Phase 1 study testing ONO-6950 in people with Healthy Adult Subjects, run by Ono Pharma USA Inc at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the safety and tolerability of ONO-6950 across ascending single doses in healthy adult male and female subjects. The secondary objectives are to characterize the pharmacokinetic and pharmacodynamic profiles of ONO-6950 by measuring plasma concentrations of ONO-6950… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Subjects
- What is being tested?
- ONO-6950
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Jun 2011
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy non-smoking male or female subjects (18-55 inclusive)
- Body mass index (BMI) of 19-35kg/m2 (inclusive)
- For females, postmenopausal, non-lactating, and non-pregnant
Who cannot join
- History or presence of clinical significant disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Placebo-Controlled, Single-Dose Escalation and Food Effect Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-6950 in Healthy Adult Subjects
The primary objective of this study is to evaluate the safety and tolerability of ONO-6950 across ascending single doses in healthy adult male and female subjects. The secondary objectives are to characterize the pharmacokinetic and pharmacodynamic profiles of ONO-6950 by measuring plasma concentrations of ONO-6950, pulmonary function, and potential cardiovascular effects. The tertiary objective of this study is to evaluate the effect of a meal upon the pharmacokinetic profile of ONO-6950.
- Conditions
- Healthy Adult Subjects
- Being tested
- ONO-6950
- Keywords
- ONO-6950, Healthy Adult Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-6950Drug
1mg, 3mg, 10mg, 30mg,100mg,300mg,1000mg at a single dose; 30mg, 100mg and 300mg for food effect study
ONO-6950Drug
1mg, 3mg, 10mg, 30mg, 100mg, 300mg, 1000mg at a single dose; 30mg, 100mg and 300mg for food effect study
| Study group | Role | What they receive |
|---|---|---|
| E | Experimental | Not described Receives: Drug: ONO-6950 |
| P | Placebo comparator | Not described Receives: Drug: ONO-6950 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of ONO-6950 using vital signs, pulmonary function tests, ECGs, laboratory tests, physical examinations
Measured: up to 7 days
Secondary outcomes (2)
Characterization of PK and PD profiles of ONO-6950, including change from baseline in pulmonary function tests, and any potential cardiovascular effects
Measured: up to 7 days
Effect of food on ONO-6950 pharmacokinetics by comparison of PK profile between fasted and fed conditions
Measured: up to 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionJun 2011
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.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ono Pharma USA Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ono Pharma USA, Inc., Study director, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01297582
- Sponsor's protocol ID
- ONO-6950POU001
- Status last verified
- Jun 2012
- First submitted
- 11 Feb 2011
- Last updated
- 14 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Single-Dose Escalation and Food Effect Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-6950 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT01297582
- Acronym / sponsor ID
- ONO-6950POU001
- Conditions
- Healthy Adult Subjects
- Keywords
- ONO-6950, Healthy Adult Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Ono Pharma USA IncIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Jun 2011 (actual)
- First posted
- 17 Feb 2011 (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.
The primary objective of this study is to evaluate the safety and tolerability of ONO-6950 across ascending single doses in healthy adult male and female subjects. The secondary objectives are to characterize the pharmacokinetic and pharmacodynamic profiles of ONO-6950 by measuring plasma concentrations of ONO-6950, pulmonary function, and potential cardiovascular effects. The tertiary objective of this study is to evaluate the effect of a meal upon the pharmacokinetic profile of ONO-6950.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E | Experimental | Drug: ONO-6950 |
| P | Placebo comparator | Drug: ONO-6950 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy non-smoking male or female subjects (18-55 inclusive)
- Body mass index (BMI) of 19-35kg/m2 (inclusive)
- For females, postmenopausal, non-lactating, and non-pregnant
Key exclusion criteria (1 listed)
- History or presence of clinical significant disease
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 |
|---|---|---|
| ONO-69501mg, 3mg, 10mg, 30mg,100mg,300mg,1000mg at a single dose; 30mg, 100mg and 300mg for food effect study | Drug | E |
| ONO-69501mg, 3mg, 10mg, 30mg, 100mg, 300mg, 1000mg at a single dose; 30mg, 100mg and 300mg for food effect study | Drug | P |
Primary outcome
Safety and tolerability of ONO-6950 using vital signs, pulmonary function tests, ECGs, laboratory tests, physical examinations
Time frame: up to 7 days
2 secondary outcomes
Characterization of PK and PD profiles of ONO-6950, including change from baseline in pulmonary function tests, and any potential cardiovascular effects
Time frame: up to 7 days
Effect of food on ONO-6950 pharmacokinetics by comparison of PK profile between fasted and fed conditions
Time frame: up to 15 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 14 Jun 2012.
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Healthy Subjects
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.
Ono Pharma USA, Inc. study director
Ono Pharmaceutical Co., Ltd.
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 ONO-6950 in people with Healthy Adult Subjects, run by Ono Pharma USA Inc at 1 site in United States.
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 3 inclusion and 1 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 14 Jun 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 United States. 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?
Safety and tolerability of ONO-6950 using vital signs, pulmonary function tests, ECGs, laboratory tests, physical examinations (time frame: up to 7 days). 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 14 Jun 2012.