Evaluation of IDX375 in healthy and hepatitis C-infected subjects

ISRCTN ISRCTN80501908
DOI https://doi.org/10.1186/ISRCTN80501908
Secondary identifying numbers IDX-09B-001
Submission date
02/07/2010
Registration date
26/08/2010
Last edited
26/08/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr John Sullivan-Bólyai
Scientific

Idenix Pharmaceuticals, Inc.
60 Hampshire Street
Cambridge
02139
United States of America

+1 617 995 9800
clinicaltrials@idenix.com

Study information

Study designTwo part randomised double-blind placebo controlled dose escalation and proof-of-concept trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the sponsor contact details below to request a patient information sheet
Scientific titleA 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
Study objectivesEvaluation of the safety, tolerability and antiviral activity of IDX375.
Ethics approval(s)1. Belgium: Secretariaat Commissie Medische Ethiek approved on the 10th March 2010
2. Moldova: National Ethic Committee approved on the 29th April 2010
Health condition(s) or problem(s) studiedGenotype 1 chronic hepatitis C virus
Intervention1. 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)IDX375
Primary outcome measure1. 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 measuresPlasma concentrations of IDX375. Measured daily during research unit confinement up to 14 days maximum, with weekly visits for follow-up.
Overall study start date09/06/2010
Completion date02/11/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit65 Years
SexBoth
Target number of participants78
Key inclusion criteriaAll 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
Key exclusion criteriaAll 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
Date of first enrolment09/06/2010
Date of final enrolment02/11/2010

Locations

Countries of recruitment

  • Belgium
  • Moldova
  • United States of America

Study participating centre

Idenix Pharmaceuticals, Inc.
Cambridge
02139
United States of America

Sponsor information

Idenix Pharmaceuticals, Inc. (USA)
Industry

c/o John Z. Sullivan-Bólyai, MD, MPH
60 Hampshire Street
Cambridge
02139
United States of America

+1 617 995 9800
clinicaltrials@idenix.com
http://www.idenix.com
ROR logo https://ror.org/02891sr49

Funders

Funder type

Industry

Idenix Pharmaceuticals, Inc. (USA)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan
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