Healthy VolunteersPhase 1NCT02684396
Phase 1, TAK-648, Single-Rising Dose Study
A Phase 1 study testing TAK-648 in people with Healthy Volunteers, run by Takeda.
Trial summary
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of TAK-648 when administered as a single oral dose of TAK-648 solution at escalating dose levels in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- TAK-648
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to Jul 2015
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Is a healthy adult male or non-pregnant, non-lactating female.
- Is aged 18 to 55 years, inclusive.
- Weighs at least 55 kg (121 lbs) and has a body mass index (BMI) between 18.0 and 30.0 kg/m^2, inclusive.
- Has a systolic blood pressure >90 and ≤150 mm Hg and a diastolic blood pressure of >60 and ≤90 mm Hg at Screening and at Check-in (Day -2).
- Has a calculated creatinine clearance >60 mL/min at Screening and Check-in (Day -2).
Who cannot join
- Has a known hypersensitivity to any component of the formulation of TAK-648, phosphodiesterase inhibitors or Listerine strips.
- Has significant medical histories or currently uncontrolled clinical conditions, which may not be safe for participant to participate in the study, may impact the participant's ability to participate in the study; may influence absorption of the study drug, or may potentially confound the study results.
- Has a history of persistent, chronic or intermittent nausea, vomiting, or diarrhea or had a current or recent (within 6 months) gastrointestinal disease that would influence the absorption of drugs
- Has a diagnosis of major depression, bipolar disorder, or anxiety disorders or received any medication to treat any psychological disorders within 1 year prior to Screening.
- Has abnormal laboratory values that suggest a clinically significant underlying disease or has the following laboratory abnormalities: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >2.5 times the upper limits of normal.
- Use of any excluded medications, supplement, or food product outlined in the protocol.
- Use of new medications during the course of the study including through the Follow-up period.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo- Controlled, Safety, Tolerability, and Pharmacokinetic Study of Escalating Single Oral TAK-648 Doses in Healthy Subjects
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of TAK-648 when administered as a single oral dose of TAK-648 solution at escalating dose levels in healthy participants.
Read the detailed description
This was a phase 1, randomized, double-blind, placebo-controlled, single-center, single-dose study in healthy participants. The study is the first TAK-648 study in humans and is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of a single dose of TAK-648 to healthy participants.
The compound being tested in this study is TAK-648. TAK-648 is being tested to find a safe and well-tolerated single dose.
This study measured how much of the study drug got into the blood stream and how long it took the body to get rid of it. Information about any side effects that may have occurred was also collected. This study was a randomized dose-rising study which means that the first group of research participants was assigned by chance to receive either the study drug or placebo. Placebo is a solution that looks like the study drug but has no active ingredient. The lowest dose of the study drug or placebo was given to the 1st group of participants (1st cohort) and a higher dose was given to the next group until all the doses of the study drug were tested. TAK-648 was dosed in 5 sequential cohorts with escalating doses from the lowest dose given in Cohort 1 to higher doses given in the subsequent cohort. Doses could be adjusted based on available safety, tolerability, and pharmacokinetic (PK) data.
Approximately 40 healthy male and female participants were planned for enrollment with 8 subjects planned (6 randomized to TAK-648 and 2 randomized to placebo) for each cohort. The study included 5 cohorts.
This single-center trial was conducted in the United States. The overall time to participate in this study was up to 45 days. Participants made multiple visits to the clinic, including one 5-day period of confinement to the clinic. All participants were contacted by telephone 14 days after the last dose of study drug and on Day 84 (+/-2 days) for a follow-up assessment.
- Conditions
- Healthy Volunteers
- Being tested
- TAK-648, TAK-648 Placebo
- Keywords
- Drug therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-648Drug
TAK-648 Solution
TAK-648 PlaceboDrug
TAK-648 placebo-matching solution
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: TAK-648 0.05 mg | Experimental | TAK-648 0.05 mg, solution, orally, once on Day 1. Receives: Drug: TAK-648 |
| Cohort 2: TAK-648 0.15 mg | Experimental | TAK-648 0.15 mg, solution, orally, once on Day 1. Receives: Drug: TAK-648 |
| Cohort 3: TAK-648 0.35 mg | Experimental | TAK-648 0.35 mg, solution, orally, once on Day 1. Receives: Drug: TAK-648 |
| Cohort 4: TAK-648 0.7 mg | Experimental | TAK-648 0.7 mg, solution, orally, once on Day 1. Receives: Drug: TAK-648 |
| Cohort 5: TAK-648 0.85 mg | Experimental | TAK-648 0.85 mg, solution, orally, once on Day 1. Receives: Drug: TAK-648 |
| Cohort 1-5: Placebo | Placebo comparator | TAK-648 placebo-matching solution, orally, once on Day 1. Receives: Drug: TAK-648 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Have at Least One Treatment-Emergent Adverse Event (TEAE)
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Measured: Day 1 to Day 14
Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Safety Laboratory Tests at Least Once Post-dose
The percentage of participants with any markedly abnormal standard safety laboratory values (chemistry, hematology and urinalysis) collected throughout study.
Measured: Day 1 to Day 4
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Signs Measurements at Least Once Post-dose
Vital signs will include body temperature (oral), sitting blood pressure (after the participant has rested for at least 5 minutes), respiration rate and pulse (bpm).
Measured: Day 1 to Day 4
Percentage of Participants With at Least One Occurrence of Severe Hypoglycemia Post-dose
Severe hypoglycemia is defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
Measured: Day 1 to Day 4
Secondary outcomes (4)
Cmax: Maximum Observed Plasma Concentration for TAK-648
Measured: Multiple time-points (up to 72 hours) post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-648
Measured: Multiple time-points (up to 72 hours) post-dose
AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-648
Measured: Multiple time-points (up to 72 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-648
Measured: Multiple time-points (up to 72 hours) post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2016 (estimated)
- Study startAug 2014
- Primary completionApr 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by TakedaThe 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director Clinical Science, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02684396
- Sponsor's protocol ID
- TAK-648_101
- Other IDs
- U1111-1154-2329
- Status last verified
- Apr 2016
- First submitted
- 16 Feb 2016
- Last updated
- 13 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo- Controlled, Safety, Tolerability, and Pharmacokinetic Study of Escalating Single Oral TAK-648 Doses in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02684396
- Acronym / sponsor ID
- TAK-648_101
- Conditions
- Healthy Volunteers
- Keywords
- Drug therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 18 Feb 2016 (estimated)
- Results
- Posted 13 Jul 2016
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 this study is to determine the safety, tolerability and pharmacokinetics of TAK-648 when administered as a single oral dose of TAK-648 solution at escalating dose levels in healthy participants.
Detailed description
This was a phase 1, randomized, double-blind, placebo-controlled, single-center, single-dose study in healthy participants. The study is the first TAK-648 study in humans and is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of a single dose of TAK-648 to healthy participants.
The compound being tested in this study is TAK-648. TAK-648 is being tested to find a safe and well-tolerated single dose.
This study measured how much of the study drug got into the blood stream and how long it took the body to get rid of it. Information about any side effects that may have occurred was also collected. This study was a randomized dose-rising study which means that the first group of research participants was assigned by chance to receive either the study drug or placebo. Placebo is a solution that looks like the study drug but has no active ingredient. The lowest dose of the study drug or placebo was given to the 1st group of participants (1st cohort) and a higher dose was given to the next group until all the doses of the study drug were tested. TAK-648 was dosed in 5 sequential cohorts with escalating doses from the lowest dose given in Cohort 1 to higher doses given in the subsequent cohort. Doses could be adjusted based on available safety, tolerability, and pharmacokinetic (PK) data.
Approximately 40 healthy male and female participants were planned for enrollment with 8 subjects planned (6 randomized to TAK-648 and 2 randomized to placebo) for each cohort. The study included 5 cohorts.
This single-center trial was conducted in the United States. The overall time to participate in this study was up to 45 days. Participants made multiple visits to the clinic, including one 5-day period of confinement to the clinic. All participants were contacted by telephone 14 days after the last dose of study drug and on Day 84 (+/-2 days) for a follow-up assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: TAK-648 0.05 mg | Experimental | Drug: TAK-648TAK-648 0.05 mg, solution, orally, once on Day 1. |
| Cohort 2: TAK-648 0.15 mg | Experimental | Drug: TAK-648TAK-648 0.15 mg, solution, orally, once on Day 1. |
| Cohort 3: TAK-648 0.35 mg | Experimental | Drug: TAK-648TAK-648 0.35 mg, solution, orally, once on Day 1. |
| Cohort 4: TAK-648 0.7 mg | Experimental | Drug: TAK-648TAK-648 0.7 mg, solution, orally, once on Day 1. |
| Cohort 5: TAK-648 0.85 mg | Experimental | Drug: TAK-648TAK-648 0.85 mg, solution, orally, once on Day 1. |
| Cohort 1-5: Placebo | Placebo comparator | Drug: TAK-648 PlaceboTAK-648 placebo-matching solution, orally, once on Day 1. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Is a healthy adult male or non-pregnant, non-lactating female.
- Is aged 18 to 55 years, inclusive.
- Weighs at least 55 kg (121 lbs) and has a body mass index (BMI) between 18.0 and 30.0 kg/m^2, inclusive.
- Has a systolic blood pressure >90 and ≤150 mm Hg and a diastolic blood pressure of >60 and ≤90 mm Hg at Screening and at Check-in (Day -2).
- Has a calculated creatinine clearance >60 mL/min at Screening and Check-in (Day -2).
Key exclusion criteria (7 listed)
- Has a known hypersensitivity to any component of the formulation of TAK-648, phosphodiesterase inhibitors or Listerine strips.
- Has significant medical histories or currently uncontrolled clinical conditions, which may not be safe for participant to participate in the study, may impact the participant's ability to participate in the study; may influence absorption of the study drug, or may potentially confound the study results.
- Has a history of persistent, chronic or intermittent nausea, vomiting, or diarrhea or had a current or recent (within 6 months) gastrointestinal disease that would influence the absorption of drugs
- Has a diagnosis of major depression, bipolar disorder, or anxiety disorders or received any medication to treat any psychological disorders within 1 year prior to Screening.
- Has abnormal laboratory values that suggest a clinically significant underlying disease or has the following laboratory abnormalities: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >2.5 times the upper limits of normal.
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 |
|---|---|---|
| TAK-648TAK-648 Solution | Drug | Cohort 1: TAK-648 0.05 mg, Cohort 2: TAK-648 0.15 mg, Cohort 3: TAK-648 0.35 mg, Cohort 4: TAK-648 0.7 mg, Cohort 5: TAK-648 0.85 mg |
| TAK-648 PlaceboTAK-648 placebo-matching solution | Drug | Cohort 1-5: Placebo |
Primary outcome
Percentage of Participants Who Have at Least One Treatment-Emergent Adverse Event (TEAE)
Time frame: Day 1 to Day 14
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Safety Laboratory Tests at Least Once Post-dose
Time frame: Day 1 to Day 4
The percentage of participants with any markedly abnormal standard safety laboratory values (chemistry, hematology and urinalysis) collected throughout study.
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Signs Measurements at Least Once Post-dose
Time frame: Day 1 to Day 4
Vital signs will include body temperature (oral), sitting blood pressure (after the participant has rested for at least 5 minutes), respiration rate and pulse (bpm).
Percentage of Participants With at Least One Occurrence of Severe Hypoglycemia Post-dose
Time frame: Day 1 to Day 4
Severe hypoglycemia is defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
4 secondary outcomes
Cmax: Maximum Observed Plasma Concentration for TAK-648
Time frame: Multiple time-points (up to 72 hours) post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-648
Time frame: Multiple time-points (up to 72 hours) post-dose
AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-648
Time frame: Multiple time-points (up to 72 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-648
Time frame: Multiple time-points (up to 72 hours) post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Clinical Science study director
Takeda
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TAK-648 in people with Healthy Volunteers, run by Takeda.
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 5 inclusion and 7 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 13 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 13 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants Who Have at Least One Treatment-Emergent Adverse Event (TEAE) (time frame: Day 1 to Day 14). The study lists 4 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 13 Jul 2016.