Contact information
Type
Scientific
Primary contact
Dr John Sullivan-Bólyai
ORCID ID
Contact details
Idenix Pharmaceuticals
Inc.
60 Hampshire Street
Cambridge
02139
United States of America
+1 617 995 9800
clinicaltrials@idenix.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
IDX-09B-001
Study information
Scientific title
A phase I/IIa study assessing single and multiple doses of hepatitis C virus (HCV) non-nucleoside polymerase inhibitor IDX375 in healthy and genotype 1 HCV-infected subjects
Acronym
Study hypothesis
Evaluation of the safety, tolerability and antiviral activity of IDX375.
Ethics approval
1. Belgium: Secretariaat Commissie Medische Ethiek approved on the 10th March 2010
2. Moldova: National Ethic Committee approved on the 29th April 2010
Study design
Two part randomised double-blind placebo controlled dose escalation and proof-of-concept trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the sponsor contact details below to request a patient information sheet
Condition
Genotype 1 chronic hepatitis C virus
Intervention
1. Dose escalation in healthy subjects - 8 subjects per dosing cohort, randomised 6:2 (active:placebo):
1.1. 200 mg IDX375 (or placebo) x 1 day
1.2. 400 mg IDX375 (or placebo) on days 1 and 8
1.3. 300 mg IDX375 (or placebo) x 1 day
1.4. 1200 mg IDX375 (or placebo) x 1 day
1.5. 800 mg IDX375 twice daily (BID) or (placebo BID) x 1 day
1.6. 800 mg IDX375 BID or (placebo BID) x 3 days
2. Proof-of-concept in HCV-infected subjects - 10 subjects per dosing cohort, randomised 8:2 (active:placebo):
2.1. 400 mg IDX375 BID or (placebo BID) x 3 days
2.2. 800 mg IDX375 BID or (placebo BID) x 3 days
2.3. 1200 mg IDX375 four times a day (QD) or (placebo QD) x 3 days
Total duration of treatment: maximum 3 days dosing
Total duration of follow-up: maximum 25 days follow-up
Intervention type
Drug
Phase
Not Specified
Drug names
IDX375
Primary outcome measure
1. Adverse events, physical examination, vital signs, electrocardiograms (ECGs), standard safety laboratory tests
2. Change in plasma HCV RNA, emergence of resistance mutations
Measured daily during research unit confinement up to 14 days maximum, with weekly visits for follow-up.
Secondary outcome measures
Plasma concentrations of IDX375. Measured daily during research unit confinement up to 14 days maximum, with weekly visits for follow-up.
Overall trial start date
09/06/2010
Overall trial end date
02/11/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All participants:
1. Aged 18 - 65 years
2. Body mass index (BMI) 18 - 35 kg/m^2
3. Must agree to use an acceptable double-barrier method of birth control
4. Male subject must agree not to donate sperm for 90 days after the last dose of study drug
5. Subject has provided written informed consent to participate in the study
Specific to healthy subjects:
6. Subject must be male
7. Subject must be a non-smoker
Specific to HCV-infected subjects:
8. Female subjects must be of non-childbearing potential
9. Documented clinical history compatible with chronic hepatitis C
10. Plasma HCV ribonucleic acid (RNA) greater than or equal to 5 log10 IU/mL at screening
11. HCV genotype 1
12. HCV treatment-naive
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
78
Participant exclusion criteria
All participants:
1. Co-infected with hepatitis B virus and/or human immunodeficiency virus (HIV)
2. Donated blood or had significant blood loss 60 days prior to dosing
3. Use of alcohol and/or drugs that could interfere with adherence to study requirements as judged by the Investigator
4. Use of other investigational drugs within 60 days of dosing, or plans to enrol in another clinical trial of an investigational agent while participating in the present study
5. Subject with known allergy to the study medication or any of its components
6. Clinically significant laboratory or electrocardiogram (ECG) abnormalities
7. Any clinically significant medical condition that, in the opinion of the Investigator, would jeopardise the safety of the subject or impact the validity of the study results
Specific to healthy subjects:
8. Concomitant use of prescription medications or systemic over-the-counter (OTC) medications. A washout period of at least 5 half-lives must be observed prior to study drug dosing, if the Investigator feels that the medication can be safely discontinued for the duration of the study.
9. Positive screen for anti-HCV antibody
Specific to HCV-infected subjects:
10. Subject is pregnant or breastfeeding
11. History or signs of decompensated liver disease: Child-Pugh class B or C, ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, or other clinical signs of portal hypertension or hepatic insufficiency
12. History of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC
Recruitment start date
09/06/2010
Recruitment end date
02/11/2010
Locations
Countries of recruitment
Belgium, Moldova
Trial participating centre
Idenix Pharmaceuticals, Inc.
Cambridge
02139
United States of America
Sponsor information
Organisation
Idenix Pharmaceuticals, Inc. (USA)
Sponsor details
c/o John Z. Sullivan-Bólyai
MD
MPH
60 Hampshire Street
Cambridge
02139
United States of America
+1 617 995 9800
clinicaltrials@idenix.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Idenix Pharmaceuticals, Inc. (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list