AzTrials
AzTrials

Hepatitis CPhase 1NCT01593735

A Multiple Dose Study to Evaluate the Safety and Efficacy of MK-2748 in Hepatitis C-Infected Participants (MK-2748-002 AM1)

A Phase 1 study testing MK-2748 in people with Hepatitis C, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a multiple dose study of the safety and efficacy of MK-2748 to be done in 2 Parts. Part I will enroll genotype 1 (GT1) hepatitis C virus (HCV)-infected participants and Part II will enroll genotype 3 (GT3) HCV-infected participants. Both Parts may run concurrently or may be staggered. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Hepatitis C
What is being tested?
MK-2748
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
No sites listed yet
Study dates
May 2012to Feb 2013
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

  • Clinical diagnosis of chronic HCV infection (GT1 or GT3) for at least 6 months and detectable HCV-RNA in peripheral blood
  • Body mass index (BMI) of 18 to 37 kg/m^2
  • No clinically significant abnormality on electrocardiogram (ECG)
  • Stable health
  • Willing to use appropriate contraception throughout the study and for 90 days after last dose of study drug

Who cannot join

  • Participant is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study
  • History of stroke, chronic seizures, or major neurological disorder
  • History of clinically significant endocrine, gastrointestinal (excepting HCV infection), cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
  • History of neoplastic disease (exceptions of adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix, or other malignancies which have been successfully treated ≥10 years prior and unlikely to recur
  • Positive Hepatitis B surface antigen
  • Documented human immunodeficiency virus (HIV) infection
Show all 16Show fewer
  • Consumption of excessive amounts of alcohol, defined as greater than 2 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer [284 mL/10 ounces],wine [125 mL/4 ounces], or distilled spirits [25 mL/1 ounce]) per day
  • Consumption of excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) or coffee, tea, cola, or other caffeinated beverages per day
  • Major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to study enrollment
  • History of significant multiple and/or severe allergies (including latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
  • Current regular user (including "recreational use") of any illicit drugs or history of drug (including alcohol) abuse within approximately 2 months prior to enrollment
  • Evidence or history of chronic hepatitis not caused by HCV including but not limited to non-HCV viral hepatitis, non-alcoholic steatohepatitis (NASH), drug induced hepatitis, autoimmune hepatitis
  • Previous treatment with other HCV NS3/4A protease inhibitors
  • Previous exposure to interferon-alpha and/or ribavirin within 3 months prior to study enrollment
  • Clinical or laboratory evidence of advanced or decompensated liver disease; evidence of bridging fibrosis or higher grade fibrosis (Metavir score ≥3)
  • Participation in another investigational study within 4 weeks prior to enrollment

About this study

Official title: A Multiple Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-2748 in Hepatitis C-Infected Participants

This is a multiple dose study of the safety and efficacy of MK-2748 to be done in 2 Parts. Part I will enroll genotype 1 (GT1) hepatitis C virus (HCV)-infected participants and Part II will enroll genotype 3 (GT3) HCV-infected participants. Both Parts may run concurrently or may be staggered.

Conditions
Hepatitis C
Being tested
MK-2748, Placebo
Medical subject headings
Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MK-2748Drug

    MK-2748 tablets, orally, once daily for 7 days, dose level dependent on Panel assignment

  • PlaceboDrug

    Placebo tablets, orally, once daily for 7 days

Study groups in NCT01593735
Study groupRoleWhat they receive
Panel A: GT1, low doseExperimentalParticipants with genotype 1 (GT1) Hepatitis C Virus (HCV) will receive low dose MK-2748 daily for 7 days.
Receives: Drug: MK-2748; Drug: Placebo
Panel B: GT1, lower doseExperimentalParticipants with GT1 HCV will receive lower dose MK-2748 daily for 7 days.
Receives: Drug: MK-2748; Drug: Placebo
Panel C: GT1, dose based on Panels A+BExperimentalParticipants with GT1 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panels A (low dose) and B (lower dose).
Receives: Drug: MK-2748; Drug: Placebo
Panel G: GT1, dose based on Panels A+B+CExperimentalParticipants with GT1 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panels A (low dose), B (lower dose), and C.
Receives: Drug: MK-2748; Drug: Placebo
Panel H: GT1, dose based on Panels A+B+C+GExperimentalParticipants with GT1 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panels A (low dose), B (lower dose), C, and G.
Receives: Drug: MK-2748; Drug: Placebo
Panel D: GT3, low dose (Omitted)ExperimentalParticipants with genotype 3 (GT3) HCV were to receive low dose MK-2748 daily for 7 days. Panel D was omitted from the study design and participants were not enrolled in this panel.
Receives: Drug: MK-2748; Drug: Placebo
Panel E: GT3, high doseExperimentalParticipants with genotype 3 (GT3) HCV will receive high dose MK-2748 daily for 7 days.
Receives: Drug: MK-2748; Drug: Placebo
Panel F: GT3, dose based on Panel EExperimentalParticipants with GT3 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panel E (high dose).
Receives: Drug: MK-2748; Drug: Placebo
Panel I: GT3, dose based on Panels E+FExperimentalParticipants with GT3 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panels E (high dose) and F.
Receives: Drug: MK-2748; Drug: Placebo
Panel J: GT3, dose based on Panels E+F+IExperimentalParticipants with GT3 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panels E (high dose), F, and I.
Receives: Drug: MK-2748; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in HCV RNA viral load (log 10 copies/mL) in GT1 HCV-infected participants

    Measured: Predose on Day 1 through Day 56

  2. Change from baseline in HCV RNA viral load (log 10 copies/mL) in GT3 HCV-infected participants

    Measured: Predose on Day 1 through Day 56

  3. Number of participants experiencing clinical or laboratory adverse events (AEs)

    Measured: From first dose up to 21 days

  4. Number of participants discontinued from study treatment due to AEs

    Measured: From Day 1 through Day 7

Secondary outcomes (2)

  1. Area under the plasma concentration curve from Hour 0 to Hour 24 (AUC0-24hr) for MK-2748

    Measured: Day 1 and Day 7, predose through 24 hours post-dose

  2. Plasma concentration of MK-2748 (C24) on Day 7 of dosing

    Measured: 24 hours post-dose on Day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2012 (estimated)
  2. Study startMay 2012
  3. Primary completionFeb 2013
  4. Study completionFeb 2013

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01593735
Sponsor's protocol ID
2748-002
Other IDs
2011-006296-18
Status last verified
Jan 2015
First submitted
4 May 2012
Last updated
22 Jan 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MK-2748 in people with Hepatitis C, run by Merck Sharp & Dohme LLC.

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 5 inclusion and 16 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 22 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

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?

Change from baseline in HCV RNA viral load (log 10 copies/mL) in GT1 HCV-infected participants (time frame: Predose on Day 1 through Day 56). The study lists 4 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 NCT01593735.

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 22 Jan 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in