HealthyPhase 1NCT02223351

Drug-Drug Interaction Study: ASP2151 and Ritonavir

A Phase 1 study testing ASP2151 and ritonavir in people with Healthy, run by Maruho Europe Limited at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: ASP2151 and ritonavir
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteUnited Kingdom
Study dates: Sep 2014to Dec 2014
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Show all 16Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Hammersmith Medicines Research Ltd
London, NW10 7EW

Other trials in United Kingdom

About this study

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

Conditions: Healthy
Being tested: ASP2151, ritonavir
Keywords: HSV, HIV, Herpes, volunteers, drug-drug interaction
Medical subject headings: Herpes Simplex

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ASP2151Drug
ritonavirDrug
Also called Norvir

Study groups in NCT02223351
Study group	Role	What they receive
400mg ASP2151	Other	400mg ASP2151 alone followed by 400mg ASP2151 + 600mg ritonavir Receives: Drug: ASP2151; Drug: ritonavir
1200mg ASP2151	Other	1200mg ASP2151 alone followed by 1200mg ASP2151 + 600mg ritonavir Receives: Drug: ASP2151; Drug: ritonavir

What is being measured

The primary outcome is the main question the study is designed to answer.

Peak Plasma Concentration (Cmax) of ASP2151
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Up to 31 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2014Dec 2014

First posted22 Aug 2014 (estimated)
Study startSep 2014
Primary completionDec 2014
Study completionDec 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02223351
Sponsor's protocol ID: M522101-EU22
Other IDs: 2014-002174-37, 2014
Status last verified: Feb 2019
First submitted: 15 Aug 2014
Last updated: 27 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02223351
Acronym / sponsor ID: M522101-EU22
Conditions: Healthy
Keywords: HSV, HIV, Herpes, volunteers, drug-drug interaction
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Maruho Europe LimitedIndustry (pharma, biotech, devices)
Study start: Sep 2014
Primary completion: Dec 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 22 Aug 2014 (estimated)
Results: Posted 11 Jan 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
400mg ASP2151	Other	Drug: ASP2151, Drug: ritonavir400mg ASP2151 alone followed by 400mg ASP2151 + 600mg ritonavir
1200mg ASP2151	Other	Drug: ASP2151, Drug: ritonavir1200mg ASP2151 alone followed by 1200mg ASP2151 + 600mg ritonavir

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (16 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ASP2151	Drug	1200mg ASP2151, 400mg ASP2151
ritonavirAlso: Norvir	Drug	1200mg ASP2151, 400mg ASP2151

Primary outcome

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

1 secondary outcome

Number of Participants With Serious and Non-Serious Adverse Events
Time frame: Up to 31 days

Results and safety

Results posted to the registry on 11 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
400mg ASP2151	24	24
1200mg ASP2151	24	24

Primary outcome: 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. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	400 mg ASP2151 Alone n = 24	400mg ASP2151 With Ritonavir n = 24	1200 mg ASP2151 Alone n = 24	1200mg ASP2151 With Ritonavir n = 24
Value	1845.7 (25.4)	2518.7 (21.9)	3804 (28.8)	6211.6 (29.2)

Primary outcome: 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. Median (Full Range). Unit: h

Measure	400 mg ASP2151 Alone n = 24	400mg ASP2151 With Ritonavir n = 24	1200 mg ASP2151 Alone n = 24	1200mg ASP2151 With Ritonavir n = 24
Value	3 (1.00 to 4.00)	4 (1.00 to 10.00)	3.025 (1.00 to 4.12)	4 (2.00 to 12.00)

Primary outcome: Area Under the Curve (AUC) of ASP2151

Measure	400 mg ASP2151 Alone n = 24	400mg ASP2151 With Ritonavir n = 24	1200 mg ASP2151 Alone n = 24	1200mg ASP2151 With Ritonavir n = 24
Value	23162.4 (34.2)	60225.3 (23)	48532.3 (29.3)	162131.6 (25.3)

Primary outcome: Half-Life (t1/2) of ASP2151

Measure	400 mg ASP2151 Alone n = 24	400mg ASP2151 With Ritonavir n = 24	1200 mg ASP2151 Alone n = 24	1200mg ASP2151 With Ritonavir n = 24
Value	7.375 (14.9)	12.575 (15.9)	7.178 (17.5)	12.498 (19.6)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to 31 days after the final dose. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
400 mg ASP2151 Alone	0 of 24 (0%)	8 of 24 (33.3%)	0 of 24
400 mg ASP2151 With Ritonavir	0 of 24 (0%)	17 of 24 (70.8%)	0 of 24
1200 mg ASP2151 Alone	0 of 24 (0%)	15 of 24 (62.5%)	0 of 24
1200 mg ASP2151 With Ritonavir	0 of 24 (0%)	13 of 24 (54.2%)	0 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ASP2151 and ritonavir in people with Healthy, run by Maruho Europe Limited at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02223351.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2019.