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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

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).

Condition or disease Intervention/treatment Phase
Healthy Drug: ASP2151 Drug: ritonavir Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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
Study Start Date : September 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
Drug Information available for: Ritonavir

Arm Intervention/treatment
400mg ASP2151
400mg ASP2151 alone followed by 400mg ASP2151 + 600mg ritonavir
Drug: ASP2151
Drug: ritonavir
Other Name: Norvir

1200mg ASP2151
1200mg ASP2151 alone followed by 1200mg ASP2151 + 600mg ritonavir
Drug: ASP2151
Drug: ritonavir
Other Name: Norvir




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]

Secondary Outcome Measures :
  1. Number of Participants With Serious and Non-Serious Adverse Events [ Time Frame: Up to 31 days ]
    Refer to the result of adverse event.


Other Outcome Measures:
  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02223351


Locations
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United Kingdom
Hammersmith Medicines Research Ltd
London, United Kingdom, NW10 7EW
Sponsors and Collaborators
Maruho Europe Limited

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Responsible Party: Maruho Europe Limited
ClinicalTrials.gov Identifier: NCT02223351     History of Changes
Other Study ID Numbers: M522101-EU22
2014-002174-37 ( EudraCT Number )
First Posted: August 22, 2014    Key Record Dates
Results First Posted: January 11, 2019
Last Update Posted: February 27, 2019
Last Verified: February 2019

Keywords provided by Maruho Europe Limited:
HSV
HIV
Herpes
volunteers
drug-drug interaction

Additional relevant MeSH terms:
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Ritonavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors