A Phase 1 interventional study of CMX157 and placebo in Infectious Disease, sponsored by ContraVir Pharmaceuticals, Inc.. Completed at 1 site in Thailand. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-02.
Sponsored by ContraVir Pharmaceuticals, Inc. · Phase 1, Interventional, and Treatment
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This is a phase 1 study to evaluate the safety and tolerability of multiple oral doses of CMX157 at increasing dose levels.
This is a phase 1 study to evaluate the safety and tolerability of multiple oral doses of CMX157 at increasing dose levels, in a fasted state and a fed state.
626 studies on the registry are indexed under Communicable Diseases; 128 are open to participants now.
This study's enrollment of 50 is below the median of 89 across 380 interventional studies indexed under Communicable Diseases.
Browse Communicable Diseases studies →ContraVir Pharmaceuticals, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CMX157, tablet, 5 mg, QD, 14 days versus CMX157 placebo, 5 mg, tablet, QD, 14 days
Drug: CMX157 · Drug: placebo
CMX157, tablet, 10 mg, QD, 14 days versus CMX157, placebo tablet, 10 mg, QD, 14 days
Drug: CMX157 · Drug: placebo
CMX157, tablet, 25 mg, QD, 14 days versus placebo CMX157, placebo tablet, 25 mg, QD, 14 days
Drug: CMX157 · Drug: placebo
CMX157, tablet, 50 mg, QD, 14 days versus CMX157, placebo tablet, 50 mg, QD, 14 days
Drug: CMX157 · Drug: placebo
CMX157, tablet, 100 mg, QD, 14 days versus CMX157, placebo tablet, 100 mg, QD, 14 days
Drug: CMX157 · Drug: placebo
Oral tablet
Also known as: Lipid Conjugate TFV
Oral tablet
Evaluation of the safety and tolerability of multiple oral doses of CMX157 at increasing dose levels.
Capture adverse events, physical examinations, ECGs and clinical laboratory panels.
Time frame: 28 days
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fasted state.
Measuring Cmax: the peak plasma concentration.
Time frame: 28 days
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fed state.
Measuring Cmax: the peak plasma concentration.
Time frame: 28 days
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fasted state.
Measuring Tmax: the time Cmax was observed.
Time frame: 28 days
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fed state.
Measuring Tmax: the time Cmax was observed.
Time frame: 28 days
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fasted state.
Measuring AUC: area under the plasma concentration versus time curve.
Time frame: 28 days
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fed state.
Measuring AUC: area under the plasma concentration versus time curve.
Time frame: 28 days
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fasted state.
Measuring Cmin: minimum observed plasma concentration.
Time frame: 28 days
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fed state.
Measuring Cmin: minimum observed plasma concentration.
Time frame: 28 days
Plan to share: Yes
No publications or documents are linked to this record.
The record gives a start of Apr 2016, a primary completion of Aug 2016 and a completion of Sep 2016. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tenofovir exalidex
ContraVir Pharmaceuticals, Inc.