Dose Finding StudyPhase 1NCT02153099
Safety, Tolerability and Pharmacokinetics of Escalating Single Doses of ENV8058 (TAK-058) in Healthy Participants
A Phase 1 study testing TAK-058 (ENV8058) in people with Dose Finding Study, run by Takeda at 1 site in United States.
Trial summary
The purpose of this study is to characterize the safety and tolerability profile of escalating dose levels of ENV8058 (TAK-058) solution when administered as a single oral dose in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Dose Finding Study
- What is being tested?
- TAK-058 (ENV8058)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Nov 2014
- 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
- In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
- The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures including requesting that a participant fast for any laboratory evaluations.
- Is a healthy male or female adult who is 18 to 55 years of age inclusive at the time of informed consent and study drug dosing.
- Weighs at least 45 kg (99 lbs) and has a body mass index (BMI) between 18.0 and 30.0 kg/m^2, inclusive at Screening.
- A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 12 weeks after last dose.
- A female participant with no childbearing potential, defined as the participant has been surgically sterilized (hysterectomy, bilateral oophorectomy or tubal ligation) or who are postmenopausal (defined as continuous amenorrhea of at least 2 years and follicle-stimulating hormone (FSH)>40 IU/L).
Who cannot join
- Has received any investigational compound within 30 days prior to the first dose of study medication.
- Is an immediate family member, study site employee, or is in a dependant relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
- Has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine disease, or psychiatric disorder, or other abnormality, which may impact the ability of the participant to participate or potentially confound the study results.
- Has a known hypersensitivity to any component of the formulation of ENV8058 (TAK-058).
- Has a positive urine drug result for drugs of abuse at Screening or Check-in (Day -1).
- Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the Screening Visit or is unwilling to agree to abstain from alcohol and drugs throughout the study.
Show all 23Show fewer
- Has taken any excluded medication, supplements, or food products listed in the Excluded Medications and Dietary Products table.
- If female, the participant is of childbearing potential (e.g premenopausal, not sterilized).
- If male, the participant intends to donate sperm during the course of this study or for 12 weeks thereafter.
- Has evidence of current cardiovascular, central nervous system, hepatic, hematopoietic disease, renal dysfunction, metabolic or endocrine dysfunction, serious allergy, asthma hypoxemia, hypertension, seizures, or allergic skin rash. There is any finding in the participant's medical history, physical examination, or safety laboratory tests giving reasonable suspicion of a disease that would contraindicate taking ENV8058 (TAK-058), or a similar drug in the same class, or that might interfere with the conduct of the study. This includes, but is not limited to seizure disorders and cardiac arrhythmias.
- Has previously had a seizure or convulsion (lifetime), including absence seizure and febrile convulsion.
- Has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs (ie, a history of malabsorption, any surgical intervention known to impact absorption [eg, bariatric surgery or bowel resection], esophageal reflux, peptic ulcer disease, erosive esophagitis, or frequent [more than once per week] occurrence of heartburn).
- Has a history of cancer or other malignancy, except basal cell carcinoma that has been in remission for at least 5 years prior to Day 1.
- Has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or a known history of human immunodeficiency virus infection at Screening.
- Has used nicotine-containing products (including but not limited to cigarettes, electronic cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days prior to Check-in (Day -1). Cotinine test is positive at Screening or Check-in (Day -1).
- Has poor peripheral venous access.
- Has donated or lost 450 mL or more of his or her blood volume (including plasmapheresis), or had a transfusion of any blood product within 45 days prior to Day 1.
- Has a Screening or Check-in (Day -1) abnormal (clinically significant) electrocardiogram (ECG). Entry of any participant with an abnormal (not clinically significant) ECG must be approved and documented by signature by the principal investigator or medically qualified subinvestigator.
- Subject had a supine blood pressure outside the ranges of 90 to 140 mm Hg for systolic and 60 to 90 mm Hg (males) and 50 to 90 mm Hg (females) for diastolic, confirmed with 1repeat testing, at the Screening Visit or Check-in (Day -1).
- Has a resting heart rate outside the range 40 to 90 bpm, confirmed with one repeat testing, at the Screening Visit or Check-in (Day -1).
- Has a QT interval with Fridericia's correction method (QTcF) >430 ms (males) or >450 ms (females) or PR outside the range of 120 to 220 ms, confirmed with one repeat testing, at the Screening Visit or Check-in (Day -1) Visit.
- Has abnormal Screening or Check-in (Day -1) laboratory values that suggest a clinically significant underlying disease or participant with the following lab abnormalities: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >1.5 the upper limits of normal.
- Has a risk of suicide according to the Investigator's clinical judgment (eg, per Columbia-Suicide Severity Rating Scale [CSSRS] or has made a suicide attempt in the previous 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetic Study of Escalating Single Doses of ENV8058 in Healthy Subjects
The purpose of this study is to characterize the safety and tolerability profile of escalating dose levels of ENV8058 (TAK-058) solution when administered as a single oral dose in healthy adults.
Read the detailed description
The drug being tested in this study is called ENV8058 (also known as TAK-058). ENV8058 is being tested to find a safe and well-tolerated dose and to assess how ENV8058 moves throughout the body. This study will look at side effects and lab results in people who took ENV8058. This study was designed as a randomized, sequential-panel, single rising dose study.
The study population will consist of 6 Cohorts with 8 participants in each Cohort; with 6 participants randomized to receive a single dose of ENV8058, and 2 participants to receive placebo. Participants in each Cohort will receive a single dose of study drug after a 10-hour fast. The starting dose is 15 mg followed by administrations of 30, 45, 15, 75 and 150 mg.
- ENV8058 (Tak-058): 5, 15, 30, 45, 75 or 150 mg oral solution
- Placebo (dummy inactive) - this oral solution looks like the study drug but has no active ingredient
This single-centre trial will be conducted in the United States. The overall time to participate in this study is up to 14 days. Participants will make 2 visits to the clinic, including one 5-day period of confinement to the clinic. All participants will be contacted by telephone 14 days after last dose of study drug for a follow-up assessment.
- Conditions
- Dose Finding Study
- Being tested
- TAK-058 (ENV8058), Placebo
- Keywords
- Drug therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-058 (ENV8058)Drug
TAK-058 (ENV8058) oral solution
PlaceboDrug
TAK-058 (ENV8058) placebo-matching oral solution
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: TAK-058 15 mg | Experimental | TAK-058 15 mg, 100 mL oral solution, once on Day 1. Receives: Drug: TAK-058 (ENV8058) |
| Cohort 2: TAK-058 30 mg | Experimental | TAK-058 30 mg, 100 mL oral solution, once on Day 1. Receives: Drug: TAK-058 (ENV8058) |
| Cohort 3: TAK-058 45 mg | Experimental | TAK-058 45 mg, 100 mL oral solution, once on Day 1. Receives: Drug: TAK-058 (ENV8058) |
| Cohort 4: TAK-058 5 mg | Experimental | TAK-058 5 mg, 100 mL oral solution, once on Day 1. Receives: Drug: TAK-058 (ENV8058) |
| Cohort 5: TAK-058 75 mg | Experimental | TAK-058 75 mg, 100 mL oral solution, once on Day 1. Receives: Drug: TAK-058 (ENV8058) |
| Cohort 6: TAK-058 150 mg | Experimental | TAK-058 150 mg, 100 mL oral solution, once on Day 1. Receives: Drug: TAK-058 (ENV8058) |
| Cohort 1-6: Placebo | Placebo comparator | TAK-058 placebo-matching, 100 mL oral solution, once on Day 1. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after the last dose of study drug, or if a serious adverse event, within 30 days after the last dose of study drug.
Measured: Baseline up to Day 30
Percentage of Participants With Markedly Abnormal Safety Laboratory Tests
The percentage of participants with any markedly abnormal standard safety laboratory values, including hematology, serum chemistries, and urinalysis, during the treatment period.
Measured: Baseline up to Day 14
Percentage of Participants With Markedly Abnormal Vital Sign Measurements
The percentage of participants who meet markedly abnormal criteria for vital signs, including oral body temperature, respiration rate, pulse [beats per minute (bpm)], and resting blood pressure and after standing.
Measured: Baseline up to Day 14
Secondary outcomes (4)
Cmax: Maximum Observed Plasma Concentration for ENV8058 (TAK-058)
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Measured: Predose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours postdose
AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for ENV8058 (TAK-058)
(AUC(0-tlqc) is a measure of total plasma exposure to the drug from time 0 to time of the last quantifiable concentration (AUC[0-tlqc]).
Measured: Predose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours postdose
AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for ENV8058 (TAK-058)
AUC(0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.
Measured: Predose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours postdose
Terminal Elimination Half-life (T1/2) Pharmacokinetic Parameter for ENV8058 (TAK-058)
Terminal Phase Elimination Half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
Measured: Predose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionNov 2014
- Study completionNov 2014
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 Dose Finding StudyStudies 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
- 48 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
- NCT02153099
- Sponsor's protocol ID
- ENV8058_101
- Other IDs
- U1111-1154-9569
- Status last verified
- Nov 2015
- First submitted
- 29 May 2014
- Last updated
- 17 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2015. 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 Doses of ENV8058 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02153099
- Acronym / sponsor ID
- ENV8058_101
- Conditions
- Dose Finding Study
- Keywords
- Drug therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 2 Jun 2014 (estimated)
- Results
- Posted 17 Dec 2015
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 characterize the safety and tolerability profile of escalating dose levels of ENV8058 (TAK-058) solution when administered as a single oral dose in healthy adults.
Detailed description
The drug being tested in this study is called ENV8058 (also known as TAK-058). ENV8058 is being tested to find a safe and well-tolerated dose and to assess how ENV8058 moves throughout the body. This study will look at side effects and lab results in people who took ENV8058. This study was designed as a randomized, sequential-panel, single rising dose study.
The study population will consist of 6 Cohorts with 8 participants in each Cohort; with 6 participants randomized to receive a single dose of ENV8058, and 2 participants to receive placebo. Participants in each Cohort will receive a single dose of study drug after a 10-hour fast. The starting dose is 15 mg followed by administrations of 30, 45, 15, 75 and 150 mg.
- ENV8058 (Tak-058): 5, 15, 30, 45, 75 or 150 mg oral solution
- Placebo (dummy inactive) - this oral solution looks like the study drug but has no active ingredient
This single-centre trial will be conducted in the United States. The overall time to participate in this study is up to 14 days. Participants will make 2 visits to the clinic, including one 5-day period of confinement to the clinic. All participants will be contacted by telephone 14 days after last dose of study drug 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
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: TAK-058 15 mg | Experimental | Drug: TAK-058 (ENV8058)TAK-058 15 mg, 100 mL oral solution, once on Day 1. |
| Cohort 2: TAK-058 30 mg | Experimental | Drug: TAK-058 (ENV8058)TAK-058 30 mg, 100 mL oral solution, once on Day 1. |
| Cohort 3: TAK-058 45 mg | Experimental | Drug: TAK-058 (ENV8058)TAK-058 45 mg, 100 mL oral solution, once on Day 1. |
| Cohort 4: TAK-058 5 mg | Experimental | Drug: TAK-058 (ENV8058)TAK-058 5 mg, 100 mL oral solution, once on Day 1. |
| Cohort 5: TAK-058 75 mg | Experimental | Drug: TAK-058 (ENV8058)TAK-058 75 mg, 100 mL oral solution, once on Day 1. |
| Cohort 6: TAK-058 150 mg | Experimental | Drug: TAK-058 (ENV8058)TAK-058 150 mg, 100 mL oral solution, once on Day 1. |
| Cohort 1-6: Placebo | Placebo comparator | Drug: PlaceboTAK-058 placebo-matching, 100 mL oral solution, once on Day 1. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
- The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures including requesting that a participant fast for any laboratory evaluations.
- Is a healthy male or female adult who is 18 to 55 years of age inclusive at the time of informed consent and study drug dosing.
- Weighs at least 45 kg (99 lbs) and has a body mass index (BMI) between 18.0 and 30.0 kg/m^2, inclusive at Screening.
- A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 12 weeks after last dose.
Key exclusion criteria (23 listed)
- Has received any investigational compound within 30 days prior to the first dose of study medication.
- Is an immediate family member, study site employee, or is in a dependant relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
- Has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine disease, or psychiatric disorder, or other abnormality, which may impact the ability of the participant to participate or potentially confound the study results.
- Has a known hypersensitivity to any component of the formulation of ENV8058 (TAK-058).
- Has a positive urine drug result for drugs of abuse at Screening or Check-in (Day -1).
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-058 (ENV8058)TAK-058 (ENV8058) oral solution | Drug | Cohort 1: TAK-058 15 mg, Cohort 2: TAK-058 30 mg, Cohort 3: TAK-058 45 mg, Cohort 4: TAK-058 5 mg, Cohort 5: TAK-058 75 mg, Cohort 6: TAK-058 150 mg |
| PlaceboTAK-058 (ENV8058) placebo-matching oral solution | Drug | Cohort 1-6: Placebo |
Primary outcome
Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
Time frame: Baseline up to Day 30
Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after the last dose of study drug, or if a serious adverse event, within 30 days after the last dose of study drug.
Percentage of Participants With Markedly Abnormal Safety Laboratory Tests
Time frame: Baseline up to Day 14
The percentage of participants with any markedly abnormal standard safety laboratory values, including hematology, serum chemistries, and urinalysis, during the treatment period.
Percentage of Participants With Markedly Abnormal Vital Sign Measurements
Time frame: Baseline up to Day 14
The percentage of participants who meet markedly abnormal criteria for vital signs, including oral body temperature, respiration rate, pulse [beats per minute (bpm)], and resting blood pressure and after standing.
4 secondary outcomes
Cmax: Maximum Observed Plasma Concentration for ENV8058 (TAK-058)
Time frame: Predose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours postdose
AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for ENV8058 (TAK-058)
Time frame: Predose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours postdose
AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for ENV8058 (TAK-058)
Time frame: Predose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours postdose
Terminal Elimination Half-life (T1/2) Pharmacokinetic Parameter for ENV8058 (TAK-058)
Time frame: Predose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours postdose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2015.
- 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
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 TAK-058 (ENV8058) in people with Dose Finding Study, run by Takeda 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 6 inclusion and 23 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 17 Dec 2015. 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?
Yes. Results are posted in the registry (first posted 17 Dec 2015). 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 Experience at Least One Treatment Emergent Adverse Event (TEAE) (time frame: Baseline up to Day 30). The study lists 3 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 17 Dec 2015.