HealthyPhase 1NCT01998659
Single Ascending Oral Dose Phase I Study With Px-102
A Phase 1 study testing Px-102 in people with Healthy, run by Phenex Pharmaceuticals AG at 1 site in Germany.
Trial summary
The purpose of this study is to assess the safety and tolerability of the FXR agonist Px-102 in healthy subjects after single oral dosing. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Px-102
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2011to Dec 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subject of caucasian origin 18 to 45 years of age
- Good state of health (mentally and physically) as determined by medical history, physical examination, vital signs, ECG recording and clinical lab results.
- BMI in between 20-29 kg/m² with absolute weight in between 70-120 kg.
- Serum triglyceride, total cholesterol and liver enzyme levels (alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyltransferase (GGT), alkaline phosphatase (AP)) strictly within the normal ranges at screening and on Day -1.
- HbA1c ≤ 6.5 %
- Subject has been informed both verbally and in writing and has given written consent to participation in the study prior to start and any study-related procedure
- Negative results for HIV- and Hepatitis-B and -C serology at screening
Who cannot join
- Female gender
- Use of prescription or non-prescription drugs within 7 days (30 if the drug is a possible enzyme inducer) prior to administration of study medication. Use of drugs known to induce steatosis (e.g. valproate, amiodarone or prednisone) or to affect body weight and carbohydrate metabolism
- Any acute or chronic illness or clinically relevant finding at screening and at base line examination which may jeopardize the subject's participation in the study
- History or presence of biliary obstruction or biliary disease, hepatic encephalopathy, advanced ascites, portal hypertension, esophageal/gastric variceal bleeding, hepatocellular carcinoma, previous liver transplantation or any other chronic liver disease
- Renal dysfunction, e.g. glomerular filtration rate ≤ 80 ml/min/1,73m2 (as determined by the formula of Cockroft-Gault)
- Type I or II Diabetes
Show all 21Show fewer
- Any clinically relevant abnormality on screening medical assessment, laboratory examination, 12-lead ECG Any clinically relevant finding in the baseline telemetry
- Marked baseline prolongation of QT/QTc interval (QTc interval > 440 ms) in the 12-lead ECG using the Fridericia method for QTc analysis
- Heart rate < 50 bpm.
- Allergies (except for mild forms of hay fever) or history of hypersensitivity reactions
- Smoking (regular or irregular) > 5 cigarettes (or equivalent) per day.
- Excessive alcohol drinking (more than approximately 20 g alcohol per day), unable to refrain from alcohol drinking from 48 h prior to dosing until the last pharmacokinetic blood sample has been withdrawn
- Positive test for drugs or alcohol at screening or prior to the dosing session
- History of alcoholism or drug/chemical/substance abuse within past 2 years
- Investigator deems the subject unable or unwilling to comply fully with the study protocol
- Has received clinical study medication within the last 30 days prior to this study
- Donation or loss of 400 ml or more of blood within eight (8) weeks prior to dosing
- Allergic to any of the active or inactive ingredients in the study medication
- Any other reason which the Investigator considers unsuitable for the subject to participate
- All subjects (including male subjects with partners of childbearing potential) who do not use a highly effective method of birth control (failure rate less than 1 % per year when used consistently and correctly), e.g. implants, injectables, combined oral contraceptives in combination with a barrier method, some intrauterine contraceptive devices or sexual abstinence
- Any condition or previous disease leading to puritus or itching of the skin.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized, Placebo-controlled, Dose-escalation Study of the Safety, Tolerability and Pharmacokinetics of Increasing Single Oral Doses of Px-102 to Healthy Subjects
The purpose of this study is to assess the safety and tolerability of the FXR agonist Px-102 in healthy subjects after single oral dosing.
Read the detailed description
The study is a single-centre, double-blind, randomized, placebo-controlled, parallel group phase I study with healthy male subjects receiving ascending single oral oral doses of Px-102 to assess the safety and tolerability, pharmacokinetics and pharmacodynamics.
- Conditions
- Healthy
- Being tested
- Px-102, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Px-102Drug
Px-102 drinking solution, 7 single ascending doses from 0.15 mg/kg up to 4.5 mg/kg
PlaceboDrug
Oral drinking solution
| Study group | Role | What they receive |
|---|---|---|
| Px-102 | Active comparator | Px-102 drinking solution, single dose Receives: Drug: Px-102 |
| Placebo | Placebo comparator | Placebo drinking solution, single dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of Px-102
Adverse event monitoring, laboratory values, cardiovascular monitoring. Comparison of active vs. placebo
Measured: 24h
Secondary outcomes (2)
Pharmacokinetics of Px-102 and metabolites
Plasma, Urine and fecal concentrations (ng/mL) of Px-102 and metabolites measured by LC-MS/MS. AUC, Cmax and other pk parameters, dose proportionality
Measured: pre-dose (0 hours), 15 min, 30 min, 1, 1.5, 2, 4, 6, 8, 12, 24 hours after dosing
Pharmacodynamics
Markers for FXR activation (e.G. FGF19 concentrations (pg/mL) measured by ELISA); comparison active vs. placebo
Measured: pre-dose (0 hours) and 1, 2, 4, 8, 12, and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2013 (estimated)
- Study startSep 2011
- Primary completionDec 2011
- Study completionDec 2011
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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phenex Pharmaceuticals AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Claus Kremoser, Dr., Study chair, Phenex Pharmaceuticals AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01998659
- Sponsor's protocol ID
- PHS-Px-102-I-01
- Status last verified
- Nov 2013
- First submitted
- 19 Nov 2013
- Last updated
- 4 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled, Dose-escalation Study of the Safety, Tolerability and Pharmacokinetics of Increasing Single Oral Doses of Px-102 to Healthy Subjects
- ClinicalTrials.gov ID
- NCT01998659
- Acronym / sponsor ID
- PHS-Px-102-I-01
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Phenex Pharmaceuticals AGIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 2 Dec 2013 (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 purpose of this study is to assess the safety and tolerability of the FXR agonist Px-102 in healthy subjects after single oral dosing.
Detailed description
The study is a single-centre, double-blind, randomized, placebo-controlled, parallel group phase I study with healthy male subjects receiving ascending single oral oral doses of Px-102 to assess the safety and tolerability, pharmacokinetics and pharmacodynamics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Px-102 | Active comparator | Drug: Px-102Px-102 drinking solution, single dose |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo drinking solution, single dose |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy male subject of caucasian origin 18 to 45 years of age
- Good state of health (mentally and physically) as determined by medical history, physical examination, vital signs, ECG recording and clinical lab results.
- BMI in between 20-29 kg/m² with absolute weight in between 70-120 kg.
- Serum triglyceride, total cholesterol and liver enzyme levels (alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyltransferase (GGT), alkaline phosphatase (AP)) strictly within the normal ranges at screening and on Day -1.
- HbA1c ≤ 6.5 %
Key exclusion criteria (21 listed)
- Female gender
- Use of prescription or non-prescription drugs within 7 days (30 if the drug is a possible enzyme inducer) prior to administration of study medication. Use of drugs known to induce steatosis (e.g. valproate, amiodarone or prednisone) or to affect body weight and carbohydrate metabolism
- Any acute or chronic illness or clinically relevant finding at screening and at base line examination which may jeopardize the subject's participation in the study
- History or presence of biliary obstruction or biliary disease, hepatic encephalopathy, advanced ascites, portal hypertension, esophageal/gastric variceal bleeding, hepatocellular carcinoma, previous liver transplantation or any other chronic liver disease
- Renal dysfunction, e.g. glomerular filtration rate ≤ 80 ml/min/1,73m2 (as determined by the formula of Cockroft-Gault)
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 |
|---|---|---|
| Px-102Px-102 drinking solution, 7 single ascending doses from 0.15 mg/kg up to 4.5 mg/kg | Drug | Px-102 |
| PlaceboOral drinking solution | Drug | Placebo |
Primary outcome
Safety and tolerability of Px-102
Time frame: 24h
Adverse event monitoring, laboratory values, cardiovascular monitoring. Comparison of active vs. placebo
2 secondary outcomes
Pharmacokinetics of Px-102 and metabolites
Time frame: pre-dose (0 hours), 15 min, 30 min, 1, 1.5, 2, 4, 6, 8, 12, 24 hours after dosing
Pharmacodynamics
Time frame: pre-dose (0 hours) and 1, 2, 4, 8, 12, and 24 hours
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 4 Nov 2014.
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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.
Claus Kremoser, Dr. study chair
Phenex Pharmaceuticals AG
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 Px-102 in people with Healthy, run by Phenex Pharmaceuticals AG at 1 site in Germany.
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 7 inclusion and 21 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 4 Nov 2014. 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 Germany. 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 Px-102 (time frame: 24h). 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 4 Nov 2014.