Condition category
Infections and Infestations
Date applied
02/07/2010
Date assigned
26/08/2010
Last edited
26/08/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.idenix.com

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes