Infectious DiseasePhase 1NCT02585440
A Multiple Dose Study of the Safety, Tolerability and PK of CMX157 in Healthy Subjects
A Phase 1 study testing CMX157 in people with Infectious Disease, run by ContraVir Pharmaceuticals, Inc. at 1 site in Thailand.
Trial summary
This is a phase 1 study to evaluate the safety and tolerability of multiple oral doses of CMX157 at increasing dose levels. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Infectious Disease
- What is being tested?
- CMX157
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteThailand
- Study dates
- Apr 2016to Sep 2016
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18-55.
- Capable of giving written informed consent.
- Capable of completing study requirements.
Who cannot join
- Positive result for HIV, HBV, or HCV.
- History or medical condition which could impact patient safety.
- Current or past abuse of alcohol or illicit drugs.
- Participation in another clinical trial within the past 30 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Partial-Blind, Placebo-controlled, Sequential Dose Group, Ascending, Multiple Dose Study of the Safety, Tolerability and Pharmacokinetics, With Food Effect, of CMX157 in Healthy Subjects
This is a phase 1 study to evaluate the safety and tolerability of multiple oral doses of CMX157 at increasing dose levels.
Read the detailed description
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.
- Conditions
- Infectious Disease
- Being tested
- CMX157, placebo
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMX157Drug
Also called Lipid Conjugate TFV
Oral tablet
placeboDrug
Oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | CMX157, tablet, 5 mg, QD, 14 days versus CMX157 placebo, 5 mg, tablet, QD, 14 days Receives: Drug: CMX157; Drug: placebo |
| Group B | Experimental | CMX157, tablet, 10 mg, QD, 14 days versus CMX157, placebo tablet, 10 mg, QD, 14 days Receives: Drug: CMX157; Drug: placebo |
| Group C | Experimental | CMX157, tablet, 25 mg, QD, 14 days versus placebo CMX157, placebo tablet, 25 mg, QD, 14 days Receives: Drug: CMX157; Drug: placebo |
| Group D | Experimental | CMX157, tablet, 50 mg, QD, 14 days versus CMX157, placebo tablet, 50 mg, QD, 14 days Receives: Drug: CMX157; Drug: placebo |
| Group E | Experimental | CMX157, tablet, 100 mg, QD, 14 days versus CMX157, placebo tablet, 100 mg, QD, 14 days Receives: Drug: CMX157; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Secondary outcomes (8)
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fasted state.
Measuring Cmax: the peak plasma concentration.
Measured: 28 days
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fed state.
Measuring Cmax: the peak plasma concentration.
Measured: 28 days
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fasted state.
Measuring Tmax: the time Cmax was observed.
Measured: 28 days
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fed state.
Measuring Tmax: the time Cmax was observed.
Measured: 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.
Measured: 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.
Measured: 28 days
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fasted state.
Measuring Cmin: minimum observed plasma concentration.
Measured: 28 days
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fed state.
Measuring Cmin: minimum observed plasma concentration.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2015 (estimated)
- Study startApr 2016
- Primary completionAug 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious DiseaseStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- ContraVir Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Sullivan-Bolyai, MD, MPH, Study chair, ContraVir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02585440
- Sponsor's protocol ID
- CTRV-CMX-102
- Status last verified
- Dec 2016
- First submitted
- 30 Sep 2015
- Last updated
- 2 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Partial-Blind, Placebo-controlled, Sequential Dose Group, Ascending, Multiple Dose Study of the Safety, Tolerability and Pharmacokinetics, With Food Effect, of CMX157 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02585440
- Acronym / sponsor ID
- CTRV-CMX-102
- Conditions
- Infectious Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- ContraVir Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 23 Oct 2015 (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 is a phase 1 study to evaluate the safety and tolerability of multiple oral doses of CMX157 at increasing dose levels.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: CMX157, Drug: placeboCMX157, tablet, 5 mg, QD, 14 days versus CMX157 placebo, 5 mg, tablet, QD, 14 days |
| Group B | Experimental | Drug: CMX157, Drug: placeboCMX157, tablet, 10 mg, QD, 14 days versus CMX157, placebo tablet, 10 mg, QD, 14 days |
| Group C | Experimental | Drug: CMX157, Drug: placeboCMX157, tablet, 25 mg, QD, 14 days versus placebo CMX157, placebo tablet, 25 mg, QD, 14 days |
| Group D | Experimental | Drug: CMX157, Drug: placeboCMX157, tablet, 50 mg, QD, 14 days versus CMX157, placebo tablet, 50 mg, QD, 14 days |
| Group E | Experimental | Drug: CMX157, Drug: placeboCMX157, tablet, 100 mg, QD, 14 days versus CMX157, placebo tablet, 100 mg, QD, 14 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age: 18-55.
- Capable of giving written informed consent.
- Capable of completing study requirements.
Key exclusion criteria (4 listed)
- Positive result for HIV, HBV, or HCV.
- History or medical condition which could impact patient safety.
- Current or past abuse of alcohol or illicit drugs.
- Participation in another clinical trial within the past 30 days.
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 |
|---|---|---|
| CMX157Also: Lipid Conjugate TFVOral tablet | Drug | Group A, Group B, Group C, Group D, Group E |
| placeboOral tablet | Drug | Group A, Group B, Group C, Group D, Group E |
Primary outcome
Evaluation of the safety and tolerability of multiple oral doses of CMX157 at increasing dose levels.
Time frame: 28 days
Capture adverse events, physical examinations, ECGs and clinical laboratory panels.
8 secondary outcomes
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fasted state.
Time frame: 28 days
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fed state.
Time frame: 28 days
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fasted state.
Time frame: 28 days
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fed state.
Time frame: 28 days
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fasted state.
Time frame: 28 days
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fed state.
Time frame: 28 days
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fasted state.
Time frame: 28 days
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fed state.
Time frame: 28 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 2 Feb 2017.
- Individual participant dataSharing planned: Yes
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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.
John Sullivan-Bolyai, MD, MPH study chair
ContraVir
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CMX157 in people with Infectious Disease, run by ContraVir Pharmaceuticals, Inc. at 1 site in Thailand.
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 3 inclusion and 4 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 2 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. 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. 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?
Evaluation of the safety and tolerability of multiple oral doses of CMX157 at increasing dose levels. (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2017.