- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01998659
Single Ascending Oral Dose Phase I Study With Px-102
November 3, 2014 updated by: Phenex Pharmaceuticals AG
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
54
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Neuss, Germany
- FOCUS Clinical Drug Development GmbH
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Px-102
Px-102 drinking solution, single dose
|
Px-102 drinking solution, 7 single ascending doses from 0.15 mg/kg up to 4.5 mg/kg
|
Placebo Comparator: Placebo
Placebo drinking solution, single dose
|
Oral drinking solution
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and tolerability of Px-102
Time Frame: 24h
|
Adverse event monitoring, laboratory values, cardiovascular monitoring.
Comparison of active vs. placebo
|
24h
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
|
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
|
Markers for FXR activation (e.G.
FGF19 concentrations (pg/mL) measured by ELISA); comparison active vs. placebo
|
pre-dose (0 hours) and 1, 2, 4, 8, 12, and 24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Claus Kremoser, Dr., Phenex Pharmaceuticals AG
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
November 19, 2013
First Submitted That Met QC Criteria
November 25, 2013
First Posted (Estimate)
December 2, 2013
Study Record Updates
Last Update Posted (Estimate)
November 4, 2014
Last Update Submitted That Met QC Criteria
November 3, 2014
Last Verified
November 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- PHS-Px-102-I-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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