Drug-Drug Interaction Study: ASP2151 and Ritonavir

NCT02223351 | Completed Phase 1 Results

• 2 other identifiers: M522101-EU222014-002174-37
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy

Keywords

HSV; HIV; Herpes; volunteers; drug-drug interaction

Outcome Measures

Primary Outcomes (6)

• Peak Plasma Concentration (Cmax) of ASP2151

  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

  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

  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

  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

  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

  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 Outcomes (1)

• Number of Participants With Serious and Non-Serious Adverse Events

  Up to 31 days

Other Outcomes (6)

• Peak Plasma Concentration (Cmax) of ASP1955888-00

  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 ASP1955888-00

  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 ASP1955888-00

  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

Study Arms (2)

400mg ASP2151

OTHER

400mg ASP2151 alone followed by 400mg ASP2151 + 600mg ritonavir

Drug: ASP2151; Drug: ritonavir

1200mg ASP2151

OTHER

1200mg ASP2151 alone followed by 1200mg ASP2151 + 600mg ritonavir

Drug: ASP2151; Drug: ritonavir

Interventions

ASP2151 DRUG

1200mg ASP2151; 400mg ASP2151

ritonavir DRUG

Also known as: Norvir

1200mg ASP2151; 400mg ASP2151

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maruho Europe Limited: lead

Study Sites (1)

Hammersmith Medicines Research Ltd

London, NW10 7EW, United Kingdom

Location

MeSH Terms

Conditions

Herpes Simplex

Interventions

ASP2151; Ritonavir

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Maruho Co.,Ltd. Kyoto R&D Center
• Organization: Clinical Development Dept.

ctinfo@mii.maruho.co.jp

+81-75-325-3255

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2014
• First Posted: August 22, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 27, 2019
• Results First Posted: January 11, 2019

Record last verified: 2019-02

Locations

GB (1)