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Drug-Drug Interaction Study: ASP2151 and Ciclosporin

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ClinicalTrials.gov Identifier: NCT02280421
Recruitment Status : Completed
First Posted : October 31, 2014
Results First Posted : May 3, 2019
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
Maruho Europe Limited

Brief Summary:
ASP2151 is an experimental treatment for herpes. Patients undergoing organ and tissue transplantation may be prescribed ciclosporin to suppress their immune system to give the transplant an increased chance of not being rejected. A patient with a compromised immune system is more susceptible to infections such as herpes, which will require treatment.

Condition or disease Intervention/treatment Phase
Healthy Drug: ASP2151 400mg + 100mg ciclosporin Drug: ASP2151 1200mg + 100mg ciclosporin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Single-centre, Open-label, Randomised, Cross-over, Drug-drug Interaction Study to Investigate the Effect of Repeated Oral Doses of Ciclosporin on the Single-dose Pharmacokinetics of nASP2151 in Healthy Mean
Study Start Date : October 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
ASP2151 400mg
ASP2151 400mg + 100mg ciclosporin
Drug: ASP2151 400mg + 100mg ciclosporin
ASP2151 1200mg
ASP2151 1200mg + 100mg ciclosporin
Drug: ASP2151 1200mg + 100mg ciclosporin



Primary Outcome Measures :
  1. Peak Plasma Concentration (Cmax) of ASP2151 [ Time Frame: prior to initial dose on Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after ASP2151 dosing on Day 1 and Day 7, and also 72 h after ASP2151 dosing on Day 7. ]
  2. Time of Peak Concentration (Tmax) of ASP2151 [ Time Frame: prior to initial dose on Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after ASP2151 dosing on Day 1 and Day 7, and also 72 h after ASP2151 dosing on Day 7. ]
  3. Area Under the Curve (AUC) of ASP2151 [ Time Frame: prior to initial dose on Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after ASP2151 dosing on Day 1 and Day 7, and also 72 h after ASP2151 dosing on Day 7. ]
  4. Half-Life (t1/2) of ASP2151 [ Time Frame: prior to initial dose on Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after ASP2151 dosing on Day 1 and Day 7, and also 72 h after ASP2151 dosing on Day 7. ]
  5. Apparent Total Body Clearance (CL/F) of ASP2151 From Plasma [ Time Frame: prior to initial dose on Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after ASP2151 dosing on Day 1 and Day 7, and also 72 h after ASP2151 dosing on Day 7. ]
  6. Apparent Volume of Distribution (Vd/F) of ASP2151 [ Time Frame: prior to initial dose on Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after ASP2151 dosing on Day 1 and Day 7, and also 72 h after ASP2151 dosing on Day 7. ]

Secondary Outcome Measures :
  1. Number of Participants With Serious and Non-Serious Adverse Events [ Time Frame: Up to 31 days after the Day 7 dose of ASP2151 ]
    Refer to the result of adverse event.


Other Outcome Measures:
  1. Peak Plasma Concentration (Cmax) of ASP1955888-00 [ Time Frame: prior to initial dose on Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after ASP2151 dosing on Day 1 and Day 7, and also 72 h after ASP2151 dosing on Day 7. ]
  2. Time of Peak Concentration (Tmax) of AS195588-00 [ Time Frame: prior to initial dose on Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after ASP2151 dosing on Day 1 and Day 7, and also 72 h after ASP2151 dosing on Day 7. ]
  3. Area Under the Curve (AUC) of AS195588-00 [ Time Frame: prior to initial dose on Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after ASP2151 dosing on Day 1 and Day 7, and also 72 h after ASP2151 dosing on Day 7. ]
  4. Half-Life (t1/2) of AS195588-00 [ Time Frame: prior to initial dose on Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after ASP2151 dosing on Day 1 and Day 7, and also 72 h after ASP2151 dosing on Day 7. ]
  5. Peak Plasma Concentration (Cmax) of Ciclosporin [ Time Frame: Blood samples were taken at pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 after dosing of ciclosporin on Days 6 and 7. ]
  6. Time of Peak Concentration (Tmax) of Ciclosporin [ Time Frame: Blood samples were taken at pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 after dosing of ciclosporin on Days 6 and 7. ]
  7. Area Under the Curve (AUC) of Ciclosporin [ Time Frame: Blood samples were taken at pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 after dosing of ciclosporin on Days 6 and 7. ]


Information from the National Library of Medicine

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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:

  • A body mass index (Quetelet index) in the range 18.0-30.9 kg/m2.
  • 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.
  • Willingness to give written consent to have data entered into The Overvolunteering Prevention System (TOPS).

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), alkaline phosphatase (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.
  • Receipt of a live vaccine in the 3 months before the first dose of study medication, or planned immunisation with a live vaccine during the study.
  • Evidence of any significant bacterial, viral, fungal or parasitic infection during the 4 weeks before dosing (minor fungal nail infections will not be regarded as significant); minor infection (eg common cold) not requiring anti-infective treatment during the 2 weeks before dosing.
  • 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). See Appendix 1 for common CYP3A4 interactors/substrates.
  • 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 5 cigarettes daily.
  • Evidence of drug abuse on urine testing.
  • Positive test for hepatitis B antigen (HBsAg); or positive test for hepatitis B core antibody (HBcAb).
  • Positive test for hepatitis C, HIV1, HIV2, or active and latent tuberculosis.
  • Blood pressure and heart rate 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.
  • Possibility that the volunteer will not cooperate with the requirements of the protocol.
  • Objection by General Practitioner (GP) to volunteer entering trial.

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): NCT02280421


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: NCT02280421    
Other Study ID Numbers: M522101-EU21
First Posted: October 31, 2014    Key Record Dates
Results First Posted: May 3, 2019
Last Update Posted: May 3, 2019
Last Verified: January 2019
Keywords provided by Maruho Europe Limited:
HSV
Herpes
volunteers
drug-drug interaction
transplant
Additional relevant MeSH terms:
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Cyclosporine
Cyclosporins
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors