HealthyPhase 1NCT03110276
Study Evaluating Safety, Tolerability and Pharmacokinetics of EYP001a in Healthy Male Subjects
A Phase 1 study testing EYP001a in people with Healthy, run by Enyo Pharma.
Trial summary
The farnesoid X receptor (FXR) regulates hepatitis B virus replication through the bile acids pathway. EYP001a is a selective, synthetic FXR agonist under development for the treatment of hepatitis B. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- EYP001a
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Mar 2017
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- -
- Subjects must satisfy all of the following inclusion criteria during screening to be enrolled in the study:
- Subject has given voluntary written informed consent before performance of any study related procedure
- Subject must be 18 to 50 years of age, inclusive at screening
- Subject must have clinical chemistries, hematology, and urinalysis tests within normal, allowable limits (if out of range must be considered clinically significant to be exclusionary) and performed within 21 days of receiving first dose of study drug
- Subject must have a body mass index of between 18 and 30 kg/m2 at screening
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- Subject must have weight > 60 kg at screening
- Subject must have normal vital signs after 5 minutes resting in supine position at screening:
- 95 mm Hg < systolic blood pressure < 140 mm Hg
- 45 mm Hg < diastolic blood pressure < 90 mm Hg
- 40 bpm < pulse rate < 90 bpm
- Subject must have a normal 12-lead automatic ECG (incomplete right bundle branch block can be accepted): 120 ms < PR < 210 ms, QRS < 120 ms, corrected QT interval (QTc) (Fridericia) ≤ 450 msec at screening.
- Agree to abstain from all medication, including non-prescription and prescription medication (including vitamins and natural or herbal remedies, e.g. St. John's Wort) for 21 days before the first study day until discharge from the study (end of post study medical).
- Subject agrees to use condom from dosing through 90 days after the dose of study drug. Female partners of male subjects enrolled into this study are also recommended to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device,diaphragm, condom, or abstinence).
Who cannot join
- -
- Subjects meeting any of the following exclusion criteria are not to be enrolled in the study:
- A history of clinically significant gastrointestinal, especially peptic ulcerations, gastrointestinal bleeding, ulcerative colitis, cholecystectomy, Crohn's disease or Irritable Bowel Syndrome, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, especially those with a past history of depression, suicidal ideation or suicidal attempts, or cardiovascular disease or any other condition which, in the opinion of the principle investigator, would jeopardize the safety of the subject or impact the validity of the study results
- Acute diarrhea or constipation in the 7 days before the predicted first study day. If screen occurs >7 days before first study day, this criterion will be determined on first study day. Diarrhea will be defined as the passage of liquid feces and/or a stool frequency of > 3 times per day. Constipation will be defined as a failure to open the bowels more frequently than every other day
- Donation or loss of more than 100 mL of blood within 60 days prior to the first drug administration
- Regular alcohol consumption >21 units per week (1 Unit = 1⁄2 pint beer, 25 mL shot of 40% spirit or a 125 mL glass of wine)
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- Subject has a borderline or long QTc Fridericia interval as defined by screening readings of > 450
- Subject has participated in a drug study within 60 days prior to the first drug administration in the current study
- Subject has used any over-the-counter (OTC) medication, including vitamins, within 21 days prior to the study
- Subject has used any prescription medication within 21 days prior to the study
- Subject has been treated with any known P450 3A4 or 2D6 enzyme altering drugs within 30 days prior to the study
- Subject smoking more than 5 cigarettes per day
- Subject has sought advice from or been referred to a general practioner or counselor for abuse or misuse of alcohol, non-medical drugs, medicinal drugs or other substance abuse, e.g. solvents
- Subject has a positive blood screen for HIV, Hepatitis B surface antigen (HBsAg), and Hepatitis C Antibody and/or a positive urine screen for alcohol or drugs of abuse
- Any current or previous use of drugs such as opiates, cocaine, ecstasy, or intravenous amphetamines
- Subjects who admit to occasional past use of cannabis will not be excluded as long as they have a negative drugs-of-abuse test and have been abstinent from cannabis use for at least 3 months
- Subject has an uncontrolled inter-current illness (i.e., active infection)
- Subject has had major surgery within four weeks of study entry, or 12 months prior to study for gastrointestinal surgery.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Escalating Single- and Multiple-Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of EYP001a in Healthy Male Subjects
The farnesoid X receptor (FXR) regulates hepatitis B virus replication through the bile acids pathway. EYP001a is a selective, synthetic FXR agonist under development for the treatment of hepatitis B.
This Phase 1 study is designed primarily to evaluate the single ascending dose (SAD) followed by a multiple ascending dose (MAD) safety, tolerability, and pharmacokinetics of EYP001a in healthy male subjects.
Read the detailed description
This is a two-part, randomized, double-blind, placebo-controlled study. Healthy male subjects will be randomly assigned to receive EYP001a or placebo.
In the SAD part, up to 6 cohorts will receive EYP001a single doses of 30 mg, 60 mg, 120 mg, 250 mg, 500 mg, and 800 mg. In the MAD part, 4 cohorts will receive EYP001a doses of 60, 120, 250 and 500 mg, once daily for 14 days over 15-day period. Each cohort will include 6 active \& 2 placebo subjects. Dose escalation will depend on evaluation of safety parameters.
Participation will include up to 21-day screening period followed by dosing period (1 to 15 days). A follow-up evaluation will occur at 6 ± 2 days post final dose.
Safety and tolerability will be assessed by monitoring adverse events, laboratory values, ECG parameters, and vital signs.
- Conditions
- Healthy
- Being tested
- EYP001a, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EYP001aDrug
Also called EYP001
10 mg and 100 mg capsules. Number of capsules to be ingested will depend on the dose cohort. Administered orally once daily. Single dose (SAD) or 14 days treatment (MAD).
PlaceboDrug
Placebo capsules, identical in appearance to the EYP001a 10 mg and 100 mg capsules.
| Study group | Role | What they receive |
|---|---|---|
| EYP001a | Experimental | Not described Receives: Drug: EYP001a |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects reported with adverse events, serious adverse events
Measured: 7 days (SAD) or 21 days (MAD)
Secondary outcomes (5)
Maximum plasma concentration (Cmax) of EYP001
ng/mL
Measured: Days 1 & 2 (SAD and MAD). Days 14 & 15 (MAD)
Time to reach maximum concentration after drug administration (Tmax) of EYP001
hours
Measured: Days 1 & 2 (SAD and MAD). Days 14 & 15 (MAD)
Area under the plasma concentration-time profile (AUCtau) of EYP001
ng.h/mL
Measured: Days 1 & 2 (SAD and MAD). Days 14 & 15 (MAD)
C4 (7α-hydroxy-4-cholesten-3-one)
ng/mL
Measured: Days 1 & 2 (SAD). Days 1, 7 & 15 (MAD)
fibroblast growth factor 19 Fibroblast growth factor 19 (FGF19)
pg/mL
Measured: Days 1 & 2 (SAD). Days 1, 7 & 15 (MAD)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study startAug 2016
- Primary completionMar 2017
- Study completionMar 2017
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Planned single doses of 30 mg, 60 mg, 120 mg, 250 mg, 500 mg, and 800 mg, and planned multiple doses of 60 mg, 120 mg, 250 mg, and 500 mg, of EYP001a will be explored in this study. Subjects will be enrolled in dose escalation cohorts that will occur sequentially based upon review of safety and PK parameters.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enyo Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03110276
- Sponsor's protocol ID
- EYP001-C01
- Other IDs
- 2016-003035-37, 2016
- Status last verified
- Apr 2017
- First submitted
- 31 Mar 2017
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Escalating Single- and Multiple-Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of EYP001a in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03110276
- Acronym / sponsor ID
- EYP001-C01
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Enyo PharmaIndustry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Study start
- Aug 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 12 Apr 2017 (actual)
- 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 farnesoid X receptor (FXR) regulates hepatitis B virus replication through the bile acids pathway. EYP001a is a selective, synthetic FXR agonist under development for the treatment of hepatitis B.
This Phase 1 study is designed primarily to evaluate the single ascending dose (SAD) followed by a multiple ascending dose (MAD) safety, tolerability, and pharmacokinetics of EYP001a in healthy male subjects.
Detailed description
This is a two-part, randomized, double-blind, placebo-controlled study. Healthy male subjects will be randomly assigned to receive EYP001a or placebo.
In the SAD part, up to 6 cohorts will receive EYP001a single doses of 30 mg, 60 mg, 120 mg, 250 mg, 500 mg, and 800 mg. In the MAD part, 4 cohorts will receive EYP001a doses of 60, 120, 250 and 500 mg, once daily for 14 days over 15-day period. Each cohort will include 6 active \& 2 placebo subjects. Dose escalation will depend on evaluation of safety parameters.
Participation will include up to 21-day screening period followed by dosing period (1 to 15 days). A follow-up evaluation will occur at 6 ± 2 days post final dose.
Safety and tolerability will be assessed by monitoring adverse events, laboratory values, ECG parameters, and vital signs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Planned single doses of 30 mg, 60 mg, 120 mg, 250 mg, 500 mg, and 800 mg, and planned multiple doses of 60 mg, 120 mg, 250 mg, and 500 mg, of EYP001a will be explored in this study. Subjects will be enrolled in dose escalation cohorts that will occur sequentially based upon review of safety and PK parameters.
| Arm | Type | Receives |
|---|---|---|
| EYP001a | Experimental | Drug: EYP001a |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- -
- Subjects must satisfy all of the following inclusion criteria during screening to be enrolled in the study:
- Subject has given voluntary written informed consent before performance of any study related procedure
- Subject must be 18 to 50 years of age, inclusive at screening
- Subject must have clinical chemistries, hematology, and urinalysis tests within normal, allowable limits (if out of range must be considered clinically significant to be exclusionary) and performed within 21 days of receiving first dose of study drug
Key exclusion criteria (18 listed)
- -
- Subjects meeting any of the following exclusion criteria are not to be enrolled in the study:
- A history of clinically significant gastrointestinal, especially peptic ulcerations, gastrointestinal bleeding, ulcerative colitis, cholecystectomy, Crohn's disease or Irritable Bowel Syndrome, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, especially those with a past history of depression, suicidal ideation or suicidal attempts, or cardiovascular disease or any other condition which, in the opinion of the principle investigator, would jeopardize the safety of the subject or impact the validity of the study results
- Acute diarrhea or constipation in the 7 days before the predicted first study day. If screen occurs >7 days before first study day, this criterion will be determined on first study day. Diarrhea will be defined as the passage of liquid feces and/or a stool frequency of > 3 times per day. Constipation will be defined as a failure to open the bowels more frequently than every other day
- Donation or loss of more than 100 mL of blood within 60 days prior to the first drug administration
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 |
|---|---|---|
| EYP001aAlso: EYP00110 mg and 100 mg capsules. Number of capsules to be ingested will depend on the dose cohort. Administered orally once daily. Single dose (SAD) or 14 days treatment (MAD). | Drug | EYP001a |
| PlaceboPlacebo capsules, identical in appearance to the EYP001a 10 mg and 100 mg capsules. | Drug | Placebo |
Primary outcome
Number of subjects reported with adverse events, serious adverse events
Time frame: 7 days (SAD) or 21 days (MAD)
5 secondary outcomes
Maximum plasma concentration (Cmax) of EYP001
Time frame: Days 1 & 2 (SAD and MAD). Days 14 & 15 (MAD)
Time to reach maximum concentration after drug administration (Tmax) of EYP001
Time frame: Days 1 & 2 (SAD and MAD). Days 14 & 15 (MAD)
Area under the plasma concentration-time profile (AUCtau) of EYP001
Time frame: Days 1 & 2 (SAD and MAD). Days 14 & 15 (MAD)
C4 (7α-hydroxy-4-cholesten-3-one)
Time frame: Days 1 & 2 (SAD). Days 1, 7 & 15 (MAD)
fibroblast growth factor 19 Fibroblast growth factor 19 (FGF19)
Time frame: Days 1 & 2 (SAD). Days 1, 7 & 15 (MAD)
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 13 Apr 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EYP001a in people with Healthy, run by Enyo Pharma.
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 14 inclusion and 18 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 Apr 2017. 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?
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?
Number of subjects reported with adverse events, serious adverse events (time frame: 7 days (SAD) or 21 days (MAD)). 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 Apr 2017.