A Phase 1a/1b Study of PPI-383 in Healthy Adults and Hepatitis C Patients
NCT ID: NCT01928147
Last Updated: 2015-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
114 participants
INTERVENTIONAL
2013-08-31
2015-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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PPI-383 single dose escalation in healthy volunteers
There will be up to 10 sequential single dose cohorts to assess the bioavailability of different doses and formulations; a food effect cohort will be included.
PPI-383
Placebo
PPI-383 multiple doses in healthy volunteers
Upon completion of the single dose cohorts, an additional cohort will receive the highest well-tolerated dose from the single dose cohorts or placebo once daily for five days; up to additional cohorts may receive multiple doses of different formulations or different regimens
PPI-383
Placebo
PPI-383 multiple dose escalation in HCV Subjects
Upon completion of the single and multiple dose healthy volunteer cohorts, there will be 3, and potentially 4, sequential cohorts of HCV patients
PPI-383
Placebo
Interventions
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PPI-383
Placebo
Eligibility Criteria
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Inclusion Criteria
* Age 18 to 55 years
* Body mass index (BMI)18 to 32 kg/m2
* Males, or females of non-childbearing potential
* Age 18 to 65 years
* Chronic hepatitis C, and absence of other known liver disease
* Seropositive for HCV antibody (HCV Ab) or HCV RNA at least once previously
* Seropositive for HCV Ab at screening
* Serum HCV RNA \> 5 log10 IU/mL at screening
* HCV gt-1
* Treatment-naïve for hepatitis C:
* BMI 18 to 35 kg/m2
* Otherwise in good health, without severe or clinically significant chronic or recurrent conditions requiring frequent medical intervention or continual pharmacologic management, except for anti-hypertensive use
* No medical or psychosocial conditions that would potentially interfere with the subject's ability to comply with the study assessments or visit schedule.
Exclusion Criteria
* Signs or symptoms of decompensated liver disease
* Evidence of cirrhosis or hepatocellular carcinoma
* Diabetes Mellitus treated with insulin or hypoglycemic agents
* Asthma requiring hospital admission within the preceding 12 months
* History of alcohol abuse or illicit drug use which could interfere with a patient's compliance with the protocol requirements
* Any of the following laboratory values at screening
* Haemoglobin (Hgb) \<11 g/dL in women or 12 g/dL in men
* White blood cell count \<4,000/mm3
* Absolute neutrophil count (ANC) \< 1800 per mm3
* Platelet count \<100,000 per mm3
* Serum creatinine \> upper limit of normal (ULN) at the central study laboratory
* Serum albumin \<3.4 g/dL
* Total bilirubin \>2.0 mg/dL
* Clinically significant abnormality in the electrocardiograms (ECGs) at screening
18 Years
65 Years
ALL
Yes
Sponsors
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Presidio Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Nathaniel Brown, M.D.
Role: STUDY_DIRECTOR
Presidio Pharmaceuticals
Locations
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Investigational site
Phoenix, , Mauritius
Investigational site
London, , United Kingdom
Investigational site
London, , United Kingdom
Investigational site
London, , United Kingdom
Investigational site
London, , United Kingdom
Investigational site
Nottingham, , United Kingdom
Countries
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Other Identifiers
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PPI-383-101
Identifier Type: -
Identifier Source: org_study_id