HealthyPhase 1NCT02280421

Drug-Drug Interaction Study: ASP2151 and Ciclosporin

A Phase 1 study testing ASP2151 400mg + 100mg ciclosporin and ASP2151 1200mg + 100mg ciclosporin 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. 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. 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 400mg + 100mg ciclosporin and ASP2151 1200mg + 100mg ciclosporin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 1 siteUnited Kingdom
Study dates: Oct 2014to Jan 2015
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

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).

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), 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.

Show all 21Show fewer

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.

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, 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

Conditions: Healthy
Being tested: ASP2151 400mg + 100mg ciclosporin, ASP2151 1200mg + 100mg ciclosporin
Keywords: HSV, Herpes, volunteers, drug-drug interaction, transplant
Medical subject headings: Herpes Simplex

What participants receive

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

ASP2151 400mg + 100mg ciclosporinDrug
ASP2151 1200mg + 100mg ciclosporinDrug

Study groups in NCT02280421
Study group	Role	What they receive
ASP2151 400mg	Other	ASP2151 400mg + 100mg ciclosporin Receives: Drug: ASP2151 400mg + 100mg ciclosporin
ASP2151 1200mg	Other	ASP2151 1200mg + 100mg ciclosporin Receives: Drug: ASP2151 1200mg + 100mg ciclosporin

What is being measured

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

Peak Plasma Concentration (Cmax) of ASP2151
Measured: 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.
Time of Peak Concentration (Tmax) of ASP2151
Measured: 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.
Area Under the Curve (AUC) of ASP2151
Measured: 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.
Half-Life (t1/2) of ASP2151
Measured: 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.
Apparent Total Body Clearance (CL/F) of ASP2151 From Plasma
Measured: 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.
Apparent Volume of Distribution (Vd/F) of ASP2151
Measured: 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 outcomes (1)

Number of Participants With Serious and Non-Serious Adverse Events
Refer to the result of adverse event.
Measured: Up to 31 days after the Day 7 dose of ASP2151

Timeline

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

Oct 2014Jan 2015

First posted31 Oct 2014 (estimated)
Study startOct 2014
Primary completionJan 2015
Study completionJan 2015

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: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02280421
Sponsor's protocol ID: M522101-EU21
Status last verified: Jan 2019
First submitted: 29 Oct 2014
Last updated: 3 May 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?

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Study at a glance

From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02280421
Acronym / sponsor ID: M522101-EU21
Conditions: Healthy
Keywords: HSV, Herpes, volunteers, drug-drug interaction, transplant
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Maruho Europe LimitedIndustry (pharma, biotech, devices)
Study start: Oct 2014
Primary completion: Jan 2015 (actual)
Study completion: Jan 2015 (actual)
First posted: 31 Oct 2014 (estimated)
Results: Posted 3 May 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
ASP2151 400mg	Other	Drug: ASP2151 400mg + 100mg ciclosporinASP2151 400mg + 100mg ciclosporin
ASP2151 1200mg	Other	Drug: ASP2151 1200mg + 100mg ciclosporinASP2151 1200mg + 100mg ciclosporin

Who may qualify

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

Key inclusion criteria (4 listed)

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).

Key exclusion criteria (21 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), 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.

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 400mg + 100mg ciclosporin	Drug	ASP2151 400mg
ASP2151 1200mg + 100mg ciclosporin	Drug	ASP2151 1200mg

Primary outcome

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.
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.
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.
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.
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.
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.

1 secondary outcome

Number of Participants With Serious and Non-Serious Adverse Events
Time frame: Up to 31 days after the Day 7 dose of ASP2151

Results and safety

Results posted to the registry on 3 May 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
ASP2151 400mg	12	12
ASP2151 1200mg	12	12

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

Measure	ASP2151 400mg Alone n = 24	ASP2151 400mg With Ciclosporin n = 24	ASP2151 1200mg Alone n = 24	ASP2151 1200mg With Ciclosporin n = 24
Value	1818.0 (26.1)	1202.3 (31.5)	3573.1 (26.1)	2452.1 (31.4)

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

Measure	ASP2151 400mg Alone n = 24	ASP2151 400mg With Ciclosporin n = 24	ASP2151 1200mg Alone n = 24	ASP2151 1200mg With Ciclosporin n = 24
Value	3.00 (0.50 to 4.02)	4.00 (1.00 to 8.00)	3.00 (2.00 to 4.00)	4.00 (2.00 to 8.00)

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

Measure	ASP2151 400mg Alone n = 24	ASP2151 400mg With Ciclosporin n = 24	ASP2151 1200mg Alone n = 24	ASP2151 1200mg With Ciclosporin n = 24
Value	23307.4 (27.1)	19013.5 (31.4)	48051.2 (25.0)	37940.8 (25.9)

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

Measure	ASP2151 400mg Alone n = 24	ASP2151 400mg With Ciclosporin n = 24	ASP2151 1200mg Alone n = 24	ASP2151 1200mg With Ciclosporin n = 24
Value	7.755 (12.1)	8.593 (16.4)	7.457 (13.2)	8.326 (14.1)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 14 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ASP2151(400mg) Alone	0 of 24 (0%)	2 of 24 (8.3%)	0 of 24
Ciclosporin After ASP2151(400mg)	0 of 24 (0%)	5 of 24 (20.8%)	0 of 24
Ciclosporin With ASP2151(400mg)	0 of 24 (0%)	10 of 24 (41.7%)	0 of 24
ASP2151(1200mg) Alone	0 of 24 (0%)	3 of 24 (12.5%)	0 of 24
Ciclosporin After ASP2151(1200mg)	0 of 24 (0%)	3 of 24 (12.5%)	0 of 24
Ciclosporin With ASP2151(1200mg)	0 of 24 (0%)	11 of 24 (45.8%)	0 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 May 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 400mg + 100mg ciclosporin and ASP2151 1200mg + 100mg ciclosporin 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 4 inclusion and 21 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 3 May 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 3 May 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: 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.). 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 NCT02280421.

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 3 May 2019.