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Drug-Drug Interaction Study: ASP2151 and Ritonavir

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ClinicalTrials.gov Identifier: NCT02223351
Recruitment Status : Completed
First Posted : August 22, 2014
Results First Posted : January 11, 2019
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Maruho Europe Limited

Tracking Information
First Submitted Date  ICMJE August 15, 2014
First Posted Date  ICMJE August 22, 2014
Results First Submitted Date  ICMJE July 9, 2018
Results First Posted Date  ICMJE January 11, 2019
Last Update Posted Date February 27, 2019
Study Start Date  ICMJE September 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2019)
  • Peak Plasma Concentration (Cmax) of ASP2151 [ Time Frame: Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention ]
  • Time of Peak Concentration (Tmax) of ASP2151 [ Time Frame: Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention ]
  • Area Under the Curve (AUC) of ASP2151 [ Time Frame: Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention ]
  • Half-Life (t1/2) of ASP2151 [ Time Frame: Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention ]
  • Apparent Total Body Clearance (CL/F) of ASP2151 From Plasma [ Time Frame: Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention ]
  • Apparent Volume of Distribution (Vd/F) of ASP2151 [ Time Frame: Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 20, 2014)
  • Peak Plasma Concentration (Cmax) of ASP2151 [ Time Frame: prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post dose ]
  • Time of Peak Concentration (Tmax) of ASP2151 [ Time Frame: prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post dose ]
  • Area Under the Curve (AUC) of ASP2151 [ Time Frame: prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post dose ]
  • Half-Life (t1/2) of ASP2151 [ Time Frame: prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours post dose ]
  • Apparent Total Body Clearance (CL/F) of ASP2151 From Plasma [ Time Frame: prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post dose ]
  • Apparent Volume of Distribution (Vd/F) of ASP2151 [ Time Frame: prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post dose ]
Change History Complete list of historical versions of study NCT02223351 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2019)
Number of Participants With Serious and Non-Serious Adverse Events [ Time Frame: Up to 31 days ]
Refer to the result of adverse event.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2014)
Number of Paticipants With Serious and Non-Serious Adverse Events [ Time Frame: Up to 31 days ]
Current Other Pre-specified Outcome Measures
 (submitted: February 25, 2019)
  • Peak Plasma Concentration (Cmax) of ASP1955888-00 [ Time Frame: Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention ]
    ASP1955888-00 is a metabolite of the study drug (ASP2151)
  • Time of Peak Concentration (Tmax) of ASP1955888-00 [ Time Frame: Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention ]
    ASP1955888-00 is a metabolite of the study drug (ASP2151)
  • Area Under the Curve (AUC) of ASP1955888-00 [ Time Frame: Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention ]
    ASP1955888-00 is a metabolite of the study drug (ASP2151)
  • Half-life (t1/2) of ASP1955888-00 [ Time Frame: Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention ]
    ASP1955888-00 is a metabolite of the study drug (ASP2151)
  • Apparent Total Body Clearance (CL/F) From Plasma of ASP1955888-00 [ Time Frame: Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention ]
    ASP1955888-00 is a metabolite of the study drug (ASP2151)
  • Apparent Volume of Distribution (Vd/F) of ASP1955888-00 [ Time Frame: Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention ]
    ASP1955888-00 is a metabolite of the study drug (ASP2151)
Original Other Pre-specified Outcome Measures
 (submitted: August 20, 2014)
  • Peak Plasma Concentration (Cmax) of ASP1955888-00 [ Time Frame: prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post dose ]
    ASP1955888-00 is a metabolite of the study drug (ASP2151)
  • Time of Peak Concentration (Tmax) of ASP1955888-00 [ Time Frame: prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post dose ]
    ASP1955888-00 is a metabolite of the study drug (ASP2151)
  • Area Under the Curve (AUC) of ASP1955888-00 [ Time Frame: prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post dose ]
    ASP1955888-00 is a metabolite of the study drug (ASP2151)
  • Half-life (t1/2) of ASP1955888-00 [ Time Frame: prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post dose ]
    ASP1955888-00 is a metabolite of the study drug (ASP2151)
  • Apparent Total Body Clearance (CL/F) From Plasma of ASP1955888-00 [ Time Frame: prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post dose ]
    ASP1955888-00 is a metabolite of the study drug (ASP2151)
  • Apparent Volume of Distribution (Vd/F) of ASP1955888-00 [ Time Frame: prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post dose ]
    ASP1955888-00 is a metabolite of the study drug (ASP2151)
 
Descriptive Information
Brief Title  ICMJE Drug-Drug Interaction Study: ASP2151 and Ritonavir
Official Title  ICMJE A Single-centre, Open-label, Randomised, Crossover, Drug-drug Interaction Study to Investigate the Effect of a Single Oral Dose of Ritonavir on the Single Dose Pharmacokinetics of ASP2151 in Healthy Men
Brief Summary ASP2151 is an experimental treatment for herpes. HIV infected people are susceptible to contracting other infections because of their compromised immune system. As HIV patients will be taking drugs to treat the virus this study aims to see if ASP2151 would interact with one of the drugs that is commonly prescribed to HIV patients (ritonavir).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: ASP2151
  • Drug: ritonavir
    Other Name: Norvir
Study Arms  ICMJE
  • 400mg ASP2151
    400mg ASP2151 alone followed by 400mg ASP2151 + 600mg ritonavir
    Interventions:
    • Drug: ASP2151
    • Drug: ritonavir
  • 1200mg ASP2151
    1200mg ASP2151 alone followed by 1200mg ASP2151 + 600mg ritonavir
    Interventions:
    • Drug: ASP2151
    • Drug: ritonavir
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 20, 2014)
48
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy volunteers
  • Sufficient intelligence to understand the nature of the trial and any hazards of participating in it. Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire trial.
  • Willingness to give written consent to participate after reading the information and consent form, and after having the opportunity to discuss the trial with the investigator or his delegate.

Exclusion Criteria:

  • Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the pre-trial screening assessment that could interfere with the objectives of the trial or the safety of the volunteer.
  • Any of the following liver function tests higher than 1.5 times the ULN at the screening visit: aspartate aminotransferase (AST), alanine aminotransferase (ALT), ALP, bilirubin, gamma glutamyl transpeptidase (gamma-GT).
  • Platelet counts outside normal limits.
  • Presence of acute or chronic illness or history of chronic illness sufficient to invalidate the volunteer's participation in the trial or make it unnecessarily hazardous.
  • Clinically significant impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary heart disease, or history of any psychotic mental illness.
  • History of bleeding diathesis.
  • Surgery (eg stomach bypass) or medical condition that might affect absorption of medicines.
  • Presence or history of severe adverse reaction to any drug, history of multiple drug allergies (multiple defined as >3), or sensitivity to trial medication.
  • Use, during the 28 days before the first dose of trial medication, of any prescription medicine, or any other medicine or herbal remedy (such as St John's wort) known to interfere with the CYP3A4 metabolic pathway (unless judged as not clinical significant by the investigator and sponsor).
  • Use, during the 7 days before the first dose of trial medication, of any over-the-counter medicine, with the exception of paracetamol (acetaminophen).
  • Participation in another clinical trial of a new chemical entity or a prescription medicine within the previous 3 months.
  • Loss of more than 400 mL blood during the 3 months before the trial, eg as a blood donor.
  • Presence or history of drug or alcohol abuse, or intake of more than 21 units of alcohol weekly or more than 10 cigarettes daily.
  • Evidence of drug abuse on urine testing.
  • Positive test for hepatitis B, hepatitis C, HIV1 or HIV2.
  • Blood pressure (BP) and heart rate (HR) in seated position at the screening examination outside the ranges 90-140 mm Hg systolic, 40-90 mm Hg diastolic; heart rate 40_100 beats/min.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02223351
Other Study ID Numbers  ICMJE M522101-EU22
2014-002174-37 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Maruho Europe Limited
Study Sponsor  ICMJE Maruho Europe Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Maruho Europe Limited
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP