HealthyPhase 1NCT02852551
Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of PAT-1251 in Healthy Adult Subjects
A Phase 1 study testing PAT-1251 in people with Healthy, run by PharmAkea, Inc. at 1 site in United Kingdom.
Trial summary
A single-center, randomized, placebo-controlled study consisting of both a single ascending dose (SAD) and a multiple ascending dose (MAD) portion to evaluate the safety, tolerability, pharmacokinetics and effect of food using PAT-1251 orally administered to healthy subjects Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PAT-1251
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2016to Nov 2016
- 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
- body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive
- body weight of 50 to 100 kg, inclusive
- subjects must be in good health
Who cannot join
- male subjects who do not agree, or whose partners of childbearing potential do not agree, to use appropriate contraception
- female subjects of childbearing potential who do not agree to use 2 acceptable methods of contraception
- history of, any clinically significant major disorder
- clinically significant allergic condition
- significant history of alcoholism or drug/chemical abuse
- use of any tobacco or nicotine-containing products
- clinically significant abnormality in heart rate, blood pressure, temperature, respiration rate, electrocardiogram or clinical laboratory findings
- positive urine drugs of abuse screen or alcohol breath test
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Covance Clinical Research Unit Ltd.
Leeds, LS2 9LH
About this study
Official title: A Phase 1, Randomised, Placebo-Controlled, Ascending Single and Multiple Dose Safety, Tolerability, Pharmacokinetic and Food Effect Study of PAT-1251 in Healthy Adult Subjects
A single-center, randomized, placebo-controlled study consisting of both a single ascending dose (SAD) and a multiple ascending dose (MAD) portion to evaluate the safety, tolerability, pharmacokinetics and effect of food using PAT-1251 orally administered to healthy subjects
- Conditions
- Healthy
- Being tested
- PAT-1251, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAT-1251Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| PAT-1251 Single Dose | Experimental | Oral solution of PAT-1251, 150 - 4000 mg administered once Receives: Drug: PAT-1251 |
| Placebo Single Dose | Placebo comparator | Matching placebo solution administered once Receives: Drug: Placebo |
| PAT-1251 Multiple Dose | Experimental | Oral tablet(s) of PAT-1251 up to 2000 mg administered daily for 7 days Receives: Drug: PAT-1251 |
| Placebo Multiple Dose | Experimental | Matching placebo tablets administered daily for 7 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Determination of adverse events will include assessment of vital signs, ECG, clinical laboratory and physical examination
Measured: one to seven days
Secondary outcomes (4)
Maximum Observed Plasma Concentration (Cmax)
Measured: one to seven days
Area Under the Plasma Concentration Versus Time Curve (AUC)
Measured: one to seven days
Time to Maximum Observed Plasma Concentration (Tmax)
Comparative pharmacokinetics of single dose administered in a fasted state and following a meal
Measured: one to seven days
Terminal elimination half-life (t½)
Measured: one to seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionNov 2016
- Study completionNov 2016
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmAkea, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kevin Holme, Ph.D., Study director, PharmAkea, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02852551
- Sponsor's protocol ID
- PAT-1251-CL-001
- Status last verified
- Nov 2016
- First submitted
- 15 Jul 2016
- Last updated
- 30 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomised, Placebo-Controlled, Ascending Single and Multiple Dose Safety, Tolerability, Pharmacokinetic and Food Effect Study of PAT-1251 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT02852551
- Acronym / sponsor ID
- PAT-1251-CL-001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- PharmAkea, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 2 Aug 2016 (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.
A single-center, randomized, placebo-controlled study consisting of both a single ascending dose (SAD) and a multiple ascending dose (MAD) portion to evaluate the safety, tolerability, pharmacokinetics and effect of food using PAT-1251 orally administered to healthy subjects
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PAT-1251 Single Dose | Experimental | Drug: PAT-1251Oral solution of PAT-1251, 150 - 4000 mg administered once |
| Placebo Single Dose | Placebo comparator | Drug: PlaceboMatching placebo solution administered once |
| PAT-1251 Multiple Dose | Experimental | Drug: PAT-1251Oral tablet(s) of PAT-1251 up to 2000 mg administered daily for 7 days |
| Placebo Multiple Dose | Experimental | Drug: PlaceboMatching placebo tablets administered daily for 7 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive
- body weight of 50 to 100 kg, inclusive
- subjects must be in good health
Key exclusion criteria (8 listed)
- male subjects who do not agree, or whose partners of childbearing potential do not agree, to use appropriate contraception
- female subjects of childbearing potential who do not agree to use 2 acceptable methods of contraception
- history of, any clinically significant major disorder
- clinically significant allergic condition
- significant history of alcoholism or drug/chemical abuse
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 |
|---|---|---|
| PAT-1251 | Drug | PAT-1251 Multiple Dose, PAT-1251 Single Dose |
| Placebo | Drug | Placebo Multiple Dose, Placebo Single Dose |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: one to seven days
Determination of adverse events will include assessment of vital signs, ECG, clinical laboratory and physical examination
4 secondary outcomes
Maximum Observed Plasma Concentration (Cmax)
Time frame: one to seven days
Area Under the Plasma Concentration Versus Time Curve (AUC)
Time frame: one to seven days
Time to Maximum Observed Plasma Concentration (Tmax)
Time frame: one to seven days
Terminal elimination half-life (t½)
Time frame: one to seven 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 30 Nov 2016.
- Sponsor WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Kevin Holme, Ph.D. study director
PharmAkea, 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 PAT-1251 in people with Healthy, run by PharmAkea, Inc. at 1 site in United Kingdom.
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 8 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 Nov 2016. 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 Kingdom. 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?
Incidence of Treatment-Emergent Adverse Events (time frame: one to seven 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 30 Nov 2016.