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CompletedNCT02223351Updated Feb 27, 2019Results posted

Drug-Drug Interaction Study: ASP2151 and Ritonavir

A Phase 1 interventional study of ASP2151 and ritonavir in Healthy, sponsored by Maruho Europe Limited. Completed at 1 site in United Kingdom. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-27.

Sponsored by Maruho Europe Limited · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study 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).

02

Conditions studied

  • Healthy

Keywords

  • HSV
  • HIV
  • Herpes
  • volunteers
  • drug-drug interaction
03

In context

Lead sponsor

Maruho Europe Limited is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • Other
    400mg ASP2151

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

    Drug: ASP2151 · Drug: ritonavir

  • Other
    1200mg ASP2151

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

    Drug: ASP2151 · Drug: ritonavir

Interventions

  • DrugASP2151
  • Drugritonavir

    Also known as: Norvir

06

What researchers measure

Primary outcomes

  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 outcomes

  1. Number of Participants With Serious and Non-Serious Adverse Events

    Refer to the result of adverse event.

    Time frame: Up to 31 days

Other outcomes

  1. Peak Plasma Concentration (Cmax) of ASP1955888-00

    ASP1955888-00 is a metabolite of the study drug (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 ASP1955888-00

    ASP1955888-00 is a metabolite of the study drug (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 ASP1955888-00

    ASP1955888-00 is a metabolite of the study drug (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 ASP1955888-00

    ASP1955888-00 is a metabolite of the study drug (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) From Plasma of ASP1955888-00

    ASP1955888-00 is a metabolite of the study drug (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

  6. Apparent Volume of Distribution (Vd/F) of ASP1955888-00

    ASP1955888-00 is a metabolite of the study drug (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

07

Results

Posted Jan 11, 2019

Participant flow

Participants took part in the study at one investigative site in United Kingdom from 05-September 2014 to 04-December 2014

Participant flow — Overall Study
Milestone400mg ASP21511200mg ASP2151
Started2424
First intervention (8 days)2424
Wasout (2weeks)2424
Second intervention (8 days)2424
Completed2424
Not completed00

Outcome measures

PrimaryPeak 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
Reported as:
Geometric mean · ng/mL
Peak Plasma Concentration (Cmax) of ASP2151
ng/mL400 mg ASP2151 Alone400mg ASP2151 With Ritonavir1200 mg ASP2151 Alone1200mg ASP2151 With Ritonavir
Peak Plasma Concentration (Cmax) of ASP21511845.7 ± 25.42518.7 ± 21.93804 ± 28.86211.6 ± 29.2
PrimaryTime 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
Reported as:
Median · h
Time of Peak Concentration (Tmax) of ASP2151
h400 mg ASP2151 Alone400mg ASP2151 With Ritonavir1200 mg ASP2151 Alone1200mg ASP2151 With Ritonavir
Time of Peak Concentration (Tmax) of ASP21513 (1.00 to 4.00)4 (1.00 to 10.00)3.025 (1.00 to 4.12)4 (2.00 to 12.00)
PrimaryArea 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
Reported as:
Geometric mean · h*ng/mL
Area Under the Curve (AUC) of ASP2151
h*ng/mL400 mg ASP2151 Alone400mg ASP2151 With Ritonavir1200 mg ASP2151 Alone1200mg ASP2151 With Ritonavir
Area Under the Curve (AUC) of ASP215123162.4 ± 34.260225.3 ± 2348532.3 ± 29.3162131.6 ± 25.3
PrimaryHalf-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
Reported as:
Geometric mean · h
Half-Life (t1/2) of ASP2151
h400 mg ASP2151 Alone400mg ASP2151 With Ritonavir1200 mg ASP2151 Alone1200mg ASP2151 With Ritonavir
Half-Life (t1/2) of ASP21517.375 ± 14.912.575 ± 15.97.178 ± 17.512.498 ± 19.6
PrimaryApparent 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
Reported as:
Mean · L/h
Apparent Total Body Clearance (CL/F) of ASP2151 From Plasma
L/h400 mg ASP2151 Alone400mg ASP2151 With Ritonavir1200 mg ASP2151 Alone1200mg ASP2151 With Ritonavir
Apparent Total Body Clearance (CL/F) of ASP2151 From Plasma18.314 ± 7.26546.815 ± 1.660725.735 ± 7.57537.63 ± 1.9843
PrimaryApparent 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
Reported as:
Mean · L
Apparent Volume of Distribution (Vd/F) of ASP2151
L400 mg ASP2151 Alone400mg ASP2151 With Ritonavir1200 mg ASP2151 Alone1200mg ASP2151 With Ritonavir
Apparent Volume of Distribution (Vd/F) of ASP2151190.1 ± 56.912123.17 ± 28.366266.33 ± 79.948139.33 ± 43.231
SecondaryNumber of Participants With Serious and Non-Serious Adverse Events

Refer to the result of adverse event.

Time frame:
Up to 31 days
Reported as:
Number · participants
Number of Participants With Serious and Non-Serious Adverse Events
participants400 mg ASP2151 Alone400 mg ASP2151 With Ritonavir1200 mg ASP2151 Alone1200 mg ASP2151 Withritonavir
Non-serious adverse event8171513
serious adverse event0000
Other pre-specifiedPeak Plasma Concentration (Cmax) of ASP1955888-00

ASP1955888-00 is a metabolite of the study drug (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
Reported as:
Geometric mean · ng/mL
Peak Plasma Concentration (Cmax) of ASP1955888-00
ng/mL400 mg ASP2151 Alone400mg ASP2151 With Ritonavir1200 mg ASP2151 Alone1200mg ASP2151 With Ritonavir
Peak Plasma Concentration (Cmax) of ASP1955888-00189.9 ± 27.721.6 ± 70.7421.5 ± 36.756.2 ± 79.9
Other pre-specifiedTime of Peak Concentration (Tmax) of ASP1955888-00

ASP1955888-00 is a metabolite of the study drug (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
Reported as:
Median · h
Time of Peak Concentration (Tmax) of ASP1955888-00
h400 mg ASP2151 Alone400mg ASP2151 With Ritonavir1200 mg ASP2151 Alone1200mg ASP2151 With Ritonavir
Time of Peak Concentration (Tmax) of ASP1955888-003 (1.00 to 4.07)1.5 (1.00 to 12.07)3 (1.98 to 6.00)1.01 (0.5 to 23.98)
Other pre-specifiedArea Under the Curve (AUC) of ASP1955888-00

ASP1955888-00 is a metabolite of the study drug (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
Reported as:
Geometric mean · h*ng/mL
Area Under the Curve (AUC) of ASP1955888-00
h*ng/mL400 mg ASP2151 Alone400mg ASP2151 With Ritonavir1200 mg ASP2151 Alone1200mg ASP2151 With Ritonavir
Area Under the Curve (AUC) of ASP1955888-002636.2 ± 25.8744.4 ± 126023.1 ± 30.21646.1 ± 37.3
Other pre-specifiedHalf-life (t1/2) of ASP1955888-00

ASP1955888-00 is a metabolite of the study drug (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
Reported as:
Geometric mean · h
Half-life (t1/2) of ASP1955888-00
h400 mg ASP2151 Alone400mg ASP2151 With Ritonavir1200 mg ASP2151 Alone1200mg ASP2151 With Ritonavir
Half-life (t1/2) of ASP1955888-008.063 ± 18.140.213 ± 56.67.617 ± 18.642.197 ± 69.1
Other pre-specifiedApparent Total Body Clearance (CL/F) From Plasma of ASP1955888-00

ASP1955888-00 is a metabolite of the study drug (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
Reported as:
Mean · L/h
Apparent Total Body Clearance (CL/F) From Plasma of ASP1955888-00
L/h400 mg ASP2151 Alone400mg ASP2151 With Ritonavir1200 mg ASP2151 Alone1200mg ASP2151 With Ritonavir
Apparent Total Body Clearance (CL/F) From Plasma of ASP1955888-00156.72 ± 43.197540.93 ± 68.554207.45 ± 59.311775.35 ± 315.166
Other pre-specifiedApparent Volume of Distribution (Vd/F) of ASP1955888-00

ASP1955888-00 is a metabolite of the study drug (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
Reported as:
Mean · L
Apparent Volume of Distribution (Vd/F) of ASP1955888-00
L400 mg ASP2151 Alone400mg ASP2151 With Ritonavir1200 mg ASP2151 Alone1200mg ASP2151 With Ritonavir
Apparent Volume of Distribution (Vd/F) of ASP1955888-001840.8 ± 559.4921474 ± 4135.722340.7 ± 877.1427624.2 ± 14413.73

Adverse events

Collected over Up to 31 days after the final dose. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
400 mg ASP2151 Alone0/24 (0%)0/24 (0%)8/24 (33.3%)
400 mg ASP2151 With Ritonavir0/24 (0%)0/24 (0%)17/24 (70.8%)
1200 mg ASP2151 Alone0/24 (0%)0/24 (0%)15/24 (62.5%)
1200 mg ASP2151 With Ritonavir0/24 (0%)0/24 (0%)13/24 (54.2%)
Most frequent other events
Showing 10 of 33
Most frequent other events
Event400 mg ASP2151 Alone400 mg ASP2151 With Ritonavir1200 mg ASP2151 Alone1200 mg ASP2151 With Ritonavir
HeadacheNervous system disorders3/246/248/247/24
FatigueGeneral disorders1/244/240/240/24
RhinitisInfections and infestations0/241/243/240/24
DizzinessNervous system disorders1/242/240/241/24
NasopharyngitisInfections and infestations1/240/241/242/24
Oropharyngeal painRespiratory, thoracic and mediastinal disorders2/240/240/241/24
MigraineNervous system disorders0/240/240/241/24
ParaesthesiaNervous system disorders0/240/241/240/24
SyncopeNervous system disorders1/240/240/240/24
Catheter site related reactionGeneral disorders1/241/240/241/24

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)400mg ASP21511200mg ASP2151Total
<=18 years011
Between 18 and 65 years242347
>=65 years000
Age, Continuous
Age, Continuous(year)400mg ASP21511200mg ASP2151Total
Mean28.2 ± 6.427 ± 4.927.6 ± 5.7
Sex: Female, Male
Sex: Female, Male(Participants)400mg ASP21511200mg ASP2151Total
Female000
Male242448
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)400mg ASP21511200mg ASP2151Total
Hispanic or Latino303
Not Hispanic or Latino212445
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)400mg ASP21511200mg ASP2151Total
American Indian or Alaska Native000
Asian134
Native Hawaiian or Other Pacific Islander000
Black or African American459
White171532
More than one race213
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(Participants)400mg ASP21511200mg ASP2151Total
United Kingdom242448
08

Study locations

1 site
  • Hammersmith Medicines Research Ltd
    London, NW10 7EW, United Kingdom
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02223351
Lead sponsor
Maruho Europe Limited
Responsible party
Sponsor
First posted
Aug 22, 2014
Start date
Sep 2014
Primary completion
Dec 2014
Completion
Dec 2014
Results posted
Jan 11, 2019
Last update
Feb 27, 2019

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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