Chronic Hepatitis CPhase 1NCT01290965
Safety, PK and Efficacy of 15 Days of SCY-635 Treatment in Hepatitis C Patients
A Phase 1 study testing SCY-635 in people with Chronic Hepatitis C, run by Scynexis, Inc. at 2 sites in United States.
Trial summary
This study will examine the effectiveness of 15 days of therapy with SCY-635 in reducing hepatitis C virus (HCV) RNA levels. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- SCY-635
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2007to Jan 2009
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A potential subject will be eligible for participation in this study if he or she meets all of the following inclusion criteria:
- The subject is either male or female, between the ages of 18 and 65 years (inclusive).
- The subject has read and signed a Subject Informed Consent form to participate in the study. If the subject is not fluent in English, the Subject Informed Consent form must be translated into his or her native language.
- Female subjects of childbearing potential (i.e., women not surgically sterile or at least two years postmenopausal) must agree to utilize one of the following forms of contraception from Screening through completion of the study: abstinence, barrier (condom, diaphragm with spermicide), intrauterine device (IUD), or vasectomized partner (six months minimum). Hormonal contraception (oral, transdermal, implant, or injection) is not permitted during the study period (i.e., from Screening through the Follow-up visit). Note: For women aged <50 years, postmenopausal is defined as at least two years cessation of menses. For women aged ≥50 years, postmenopausal is defined as at least one year cessation of menses. Estrogen replacement is allowed during the study.
- The subject exhibits quantifiable plasma levels of HCV-specific RNA in excess of 100,000 IU/mL as determined by the quantitative Roche COBAS taqMan assay.
- The subject has a negative urine screen for amphetamines, barbiturates, cocaine, opiates, and phencyclidine at Screening.
- If female, the subject has a negative serum pregnancy test at Screening (within 30 days prior to dosing) and a negative urine pregnancy test on Study Day -1.
Who cannot join
- A potential subject will be excluded from participation in the study if he or she meets any of the following exclusion criteria:
- The subject has a history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease, or any other condition which, in the opinion of the Principal Investigator, may jeopardize the safety of the subject or may impact the validity of the study results.
- The subject is infected with any HCV genotype other than genotype 1.
- The subject has documented positive antibody tests for Human Immunodeficiency Virus Types 1 or 2 (p24 antibody specific for HIV-1 or HIV-2) or Hepatitis B virus (HBV) surface antigen (HbSAg) or at Screening exhibits serologic evidence of infection with either HIV-1, HIV-2 or HBV.
- The subject has donated blood within 30 days prior to dosing or donated plasma within 14 days prior to dosing.
- The subject has used any investigational agent within three months prior to dosing.
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- The subject has received any FDA-approved anti-HCV therapy (including ribavirin or any product that contains interferon) within three months prior to dosing.
- The subject exhibits evidence of decompensated liver disease, as marked by bilirubin greater than 4 mg/dL, albumin less than 3.0 g/dL, prothrombin time greater than 2 seconds prolonged, or history of bleeding esophageal varices, ascites or hepatic encephalopathy.
- The subject is an organ transplant recipient.
- The subject exhibits ALT values greater than or equal to 2.5 times the upper limit of normal.
- The subject exhibits evidence of hepatocellular carcinoma either by exhibiting a serum alpha-fetoprotein concentration which exceeds 50 mg/L or by exhibiting a mass suggestive of liver cancer by ultrasound or other imaging technology.
- The subject exhibits evidence of ongoing alcohol or substance abuse.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
McGuire Veterans Affairs Medical Center
Richmond, Virginia, 23249
Quest Clinical Research
San Francisco, California, 94115
About this study
Official title: A Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics, and Effect of Treatment With SCY 635 on Plasma HCV RNA Following 15 Days of Oral Administration in Adult Patients With Chronic Hepatitis C Infection
This study will examine the effectiveness of 15 days of therapy with SCY-635 in reducing hepatitis C virus (HCV) RNA levels.
- Conditions
- Chronic Hepatitis C
- Being tested
- Placebo, SCY-635
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Oral tablet given once or three times daily for 15 consecutive days
SCY-635Drug
oral capsule
| Study group | Role | What they receive |
|---|---|---|
| Placebo comparator | Placebo comparator | Not described Receives: Drug: Placebo |
| SCY-635 30 mg once daily | Active comparator | Not described Receives: Drug: SCY-635 |
| SCY-635 100 mg once daily | Active comparator | Not described Receives: Drug: SCY-635 |
| SCY-635 300 mg once daily | Active comparator | Not described Receives: Drug: SCY-635 |
| SCY-635 100 mg three times daily | Active comparator | Not described Receives: Drug: SCY-635 |
| SCY-635 200 mg three times daily | Active comparator | Not described Receives: Drug: SCY-635 |
| SCY-635 300 mg three times daily | Active comparator | Not described Receives: Drug: SCY-635 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma HCV RNA level
Measured: 22 days
Incidence and severity of treatment-emergent adverse events and changes in laboratory values as measures of safety and tolerability.
Measured: 22 days
Secondary outcomes (1)
Pharmacokinetic assessment of SCY-635
Measured: 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2011 (estimated)
- Study startApr 2007
- Primary completionDec 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis CStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scynexis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Douglas Heuman, MD, Principal investigator, McGuire Veterans Affairs Medical Center, Richmond, VirginiaJacob Lalezari, MD, Principal investigator, Quest Clinical Research, San Francisco, California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01290965
- Sponsor's protocol ID
- SCY-635-104
- Status last verified
- Feb 2011
- First submitted
- 4 Feb 2011
- Last updated
- 6 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Hopkins S, DiMassimo B, Rusnak P, Heuman D, Lalezari J, Sluder A, Scorneaux B, Mosier S, Kowalczyk P, Ribeill Y, Baugh J, Gallay P. The cyclophilin inhibitor SCY-635 suppresses viral replication and induces endogenous interferons in patients with chronic HCV genotype 1 infection. J Hepatol. 2012 Jul;57(1):47-54. doi: 10.1016/j.jhep.2012.02.024. Epub 2012 Mar 13.
PubMed 22425702
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics, and Effect of Treatment With SCY 635 on Plasma HCV RNA Following 15 Days of Oral Administration in Adult Patients With Chronic Hepatitis C Infection
- ClinicalTrials.gov ID
- NCT01290965
- Acronym / sponsor ID
- SCY-635-104
- Conditions
- Chronic Hepatitis C
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Scynexis, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 7 Feb 2011 (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.
This study will examine the effectiveness of 15 days of therapy with SCY-635 in reducing hepatitis C virus (HCV) RNA levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Placebo comparator | Placebo comparator | Drug: Placebo |
| SCY-635 30 mg once daily | Active comparator | Drug: SCY-635 |
| SCY-635 100 mg once daily | Active comparator | Drug: SCY-635 |
| SCY-635 300 mg once daily | Active comparator | Drug: SCY-635 |
| SCY-635 100 mg three times daily | Active comparator | Drug: SCY-635 |
| SCY-635 200 mg three times daily | Active comparator | Drug: SCY-635 |
| SCY-635 300 mg three times daily | Active comparator | Drug: SCY-635 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- A potential subject will be eligible for participation in this study if he or she meets all of the following inclusion criteria:
- The subject is either male or female, between the ages of 18 and 65 years (inclusive).
- The subject has read and signed a Subject Informed Consent form to participate in the study. If the subject is not fluent in English, the Subject Informed Consent form must be translated into his or her native language.
- Female subjects of childbearing potential (i.e., women not surgically sterile or at least two years postmenopausal) must agree to utilize one of the following forms of contraception from Screening through completion of the study: abstinence, barrier (condom, diaphragm with spermicide), intrauterine device (IUD), or vasectomized partner (six months minimum). Hormonal contraception (oral, transdermal, implant, or injection) is not permitted during the study period (i.e., from Screening through the Follow-up visit). Note: For women aged <50 years, postmenopausal is defined as at least two years cessation of menses. For women aged ≥50 years, postmenopausal is defined as at least one year cessation of menses. Estrogen replacement is allowed during the study.
- The subject exhibits quantifiable plasma levels of HCV-specific RNA in excess of 100,000 IU/mL as determined by the quantitative Roche COBAS taqMan assay.
Key exclusion criteria (12 listed)
- A potential subject will be excluded from participation in the study if he or she meets any of the following exclusion criteria:
- The subject has a history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease, or any other condition which, in the opinion of the Principal Investigator, may jeopardize the safety of the subject or may impact the validity of the study results.
- The subject is infected with any HCV genotype other than genotype 1.
- The subject has documented positive antibody tests for Human Immunodeficiency Virus Types 1 or 2 (p24 antibody specific for HIV-1 or HIV-2) or Hepatitis B virus (HBV) surface antigen (HbSAg) or at Screening exhibits serologic evidence of infection with either HIV-1, HIV-2 or HBV.
- The subject has donated blood within 30 days prior to dosing or donated plasma within 14 days prior to dosing.
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 |
|---|---|---|
| PlaceboOral tablet given once or three times daily for 15 consecutive days | Drug | Placebo comparator |
| SCY-635oral capsule | Drug | SCY-635 100 mg once daily, SCY-635 100 mg three times daily, SCY-635 200 mg three times daily, SCY-635 30 mg once daily, SCY-635 300 mg once daily, SCY-635 300 mg three times daily |
Primary outcome
Plasma HCV RNA level
Time frame: 22 days
Incidence and severity of treatment-emergent adverse events and changes in laboratory values as measures of safety and tolerability.
Time frame: 22 days
1 secondary outcome
Pharmacokinetic assessment of SCY-635
Time frame: 22 days
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 6 Nov 2014.
- Derived from this study: PubMed 22425702Hopkins S, DiMassimo B, Rusnak P, Heuman D, Lalezari J, Sluder A, Scorneaux B, Mosier S, Kowalczyk P, Ribeill Y, Baugh J, Gallay P. The cyclophilin inhibitor SCY-635 suppresses viral replication and induces endogenous interferons in patients with chronic HCV genotype 1 infection. J Hepatol. 2012 Jul;57(1):47-54. doi: 10.1016/j.jhep.2012.02.024. Epub 2012 Mar 13.
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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.
Douglas Heuman, MD principal investigator
McGuire Veterans Affairs Medical Center, Richmond, Virginia
Jacob Lalezari, MD principal investigator
Quest Clinical Research, San Francisco, California
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SCY-635 in people with Chronic Hepatitis C, run by Scynexis, Inc. at 2 sites in United States.
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 12 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 6 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 2 sites in United States. 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?
Plasma HCV RNA level (time frame: 22 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01290965, which also lists 1 linked publication.
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 6 Nov 2014.