- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03493698
A Fixed-Sequence, Drug-Drug Interaction Study Between Multiple Oral Doses of Inarigivir Soproxil and a Single Oral Dose of Midazolam in Healthy Subjects
September 14, 2020 updated by: F-star Therapeutics, Inc.
A Phase 1, Open-label, Fixed-Sequence, Drug-Drug Interaction Study Between Multiple Oral Doses of Inarigivir Soproxil and a Single Oral Dose of Midazolam in Healthy Subjects
This is a single center, open-label, fixed sequence study to investigate the effect of multiple oral dosing of Inarigivir Soproxil and a single oral dose of Midazolam in Healthy Subjects
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Groningen, Netherlands
- University Medical Center Groningen
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Gender : male or female
- Age : 18-55 years, inclusive, at screening
- Body mass index (BMI) : 18.0-30.0 kg/m2, inclusive, at screening
- Status : healthy subjects
- At screening, females must be non-pregnant and non-lactating, or of non-childbearing potential (either surgically sterilized or physiologically incapable of becoming pregnant, or at least 1 year post-menopausal [amenorrhoea duration of 12 consecutive months]); non-pregnancy will be confirmed for all females by a serum pregnancy test conducted at screening, and a urine pregnancy test at each admission and at follow-up
- Female subjects of childbearing potential, with a fertile male sexual partner, must agree to use adequate contraception from screening until 90 days after the follow-up visit. Adequate contraception is defined as using a non-hormonal intrauterine device combined with at least 1 of the following forms of contraception: a diaphragm or cervical cap, or a condom; please note that hormonal contraceptives are not allowed. Also, total abstinence, in accordance with the lifestyle of the subject, is acceptable
- Male subjects, if not surgically sterilized, must agree to use adequate contraception and not donate sperm from admission to the clinical research center until 90 days after the follow-up visit. Adequate contraception for the male subject (and his female partner) is defined as using hormonal contraceptives or an intrauterine device, combined with at least 1 of the following forms of contraception: a diaphragm or cervical cap, or a condom. Also, total abstinence, in accordance with the lifestyle of the subject is acceptable
- All prescribed medication, including hormonal contraceptives for female subjects, must have been stopped at least 30 days prior to admission to the clinical research center
- All over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (eg, St. John's Wort) must have been stopped at least 14 days prior to admission to the clinical research center. An exception is made for paracetamol, which is allowed up to admission to the clinical research center
- Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, energy drinks) and grapefruit (juice) from 72 hours prior to admission to the clinical research center
- Good physical and mental health on the basis of medical history, physical examination, clinical laboratory, electrocardiogram (ECG) and vital signs, as judged by the PI
- Willing and able to sign the ICF
Exclusion Criteria:
- Employee of PRA or the Sponsor
- History of relevant drug and/or food allergies
- Using tobacco products within 60 days prior to the first drug administration
- History of alcohol abuse or drug addiction (including soft drugs like cannabis products)
- Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants and alcohol) at screening and admission to the clinical research center
- Average intake of more than 24 units of alcohol per week (1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits)
- Positive screen for hepatitis B surface antigen (HBsAg), anti-HCV antibodies or anti-human immunodeficiency virus (HIV) 1 and 2 antibodies
- Participation in a drug study within 60 days prior to the first drug administration in the current study. Participation in more than 4 other drug studies in the 12 months prior to the first drug administration in the current study
- Donation or loss of more than 100 mL of blood within 60 days prior to the first drug administration. Donation or loss of more than 1.5 liters of blood (for male subjects) / more than 1.0 liters of blood (for female subjects) in the 10 months prior to the first drug administration in the current study
- Significant and/or acute illness within 5 days prior to the first drug administration that may impact safety assessments, in the opinion of the PI
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SEQUENTIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Treatment A: Midazolam
All subjects will receive a single oral dose of 2 mg Midazolam on Day 1
|
Midazolam
|
EXPERIMENTAL: Treatment B and C: Inarigivir
All subjects will receive a single oral dose of 400 mg Inarigivir on Day 3, Day 6-18
|
Inarigivir
Other Names:
|
EXPERIMENTAL: Treatment D: Inarigivir with Midazolam
All subjects will receive a single oral dose of 400 mg Inarigivir coa administered with a single oral dose of 2 mg Midazolam on Day 19
|
Midazolam
Inarigivir
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of Steady-state Oral Inarigivir on the Single Dose Pharmacokinetics (PK) of Oral Midazolam in Healthy Subjects (Cmax)
Time Frame: Day 1 Treatment A and Day 19 Treatment D, respectively
|
Comparison of Cmax for midazolam between Treatments A and D.
|
Day 1 Treatment A and Day 19 Treatment D, respectively
|
Effect of Steady-state Oral Inarigivir on the Single Dose Pharmacokinetics (PK) of Oral Midazolam in Healthy Subjects (AUC0-t)
Time Frame: Day 1 Treatment A and Day 19 Treatment D, respectively
|
Comparison of AUC0-t for midazolam between Treatments A and D.
|
Day 1 Treatment A and Day 19 Treatment D, respectively
|
Effect of Steady-state Oral Inarigivir on the Single Dose Pharmacokinetics (PK) of Oral Midazolam in Healthy Subjects (AUC0-inf )
Time Frame: Day 1 Treatment A and Day 19 Treatment D, respectively
|
Comparison of AUC0-inf for midazolam between Treatments A and D.
|
Day 1 Treatment A and Day 19 Treatment D, respectively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Clinical Relevant Clinical Laboratory, Vital Signs, 12-lead ECG, or Physical Examination
Time Frame: Day -1 to Day 20 and Follow-up (5-9 days post-treatment)
|
Safety and tolerability were measured via clinical laboratory evaluations, vital signs, 12-lead ECG, or physical examination
|
Day -1 to Day 20 and Follow-up (5-9 days post-treatment)
|
PK of Inarigivir After Single and Multiple Oral Doses in Healthy Subjects (AUC)
Time Frame: Day 3 and Day 6 to 19
|
A summary of the main plasma PK parameters for inarigivir, Rp-SB 9000, Sp-SB 9000, and Rp-SB 9000 and Sp-SB 9000 combined after a single oral dose of 400 mg inarigivir on Day 3 (Treatment B) and after the last of 14 consecutive daily oral doses of 400 mg inarigivir from Day 6 to 19 (Treatment D)
|
Day 3 and Day 6 to 19
|
PK of Inarigivir After Single and Multiple Oral Doses in Healthy Subjects (Cmax)
Time Frame: Day 3 and Day 6 to 19
|
A summary of the main plasma PK parameters for inarigivir, Rp-SB 9000, Sp-SB 9000, and Rp-SB 9000 and Sp-SB 9000 combined after a single oral dose of 400 mg inarigivir on Day 3 (Treatment B) and after the last of 14 consecutive daily oral doses of 400 mg inarigivir from Day 6 to 19 (Treatment D)
|
Day 3 and Day 6 to 19
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jeroen van de Wetering, PRA Health Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 7, 2018
Primary Completion (ACTUAL)
August 27, 2018
Study Completion (ACTUAL)
August 27, 2018
Study Registration Dates
First Submitted
April 3, 2018
First Submitted That Met QC Criteria
April 9, 2018
First Posted (ACTUAL)
April 10, 2018
Study Record Updates
Last Update Posted (ACTUAL)
October 8, 2020
Last Update Submitted That Met QC Criteria
September 14, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Tranquilizing Agents
- Psychotropic Drugs
- Hypnotics and Sedatives
- Adjuvants, Anesthesia
- Anti-Anxiety Agents
- GABA Modulators
- GABA Agents
- Midazolam
Other Study ID Numbers
- SBP-9200-HBV-202
- 2018-000607-16 (EUDRACT_NUMBER)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Drug Interaction Potentiation
-
Akebia TherapeuticsCompletedDrug Interaction PotentiationCanada
-
Il-Yang Pharm. Co., Ltd.CompletedDrug Interaction PotentiationKorea, Republic of
-
National Taiwan University HospitalCompletedDrug Interaction PotentiationTaiwan
-
Akebia TherapeuticsCompletedDrug Interaction PotentiationCanada
-
SK Chemicals Co., Ltd.CompletedDrug Interaction Potentiation
-
Tianjin Medical University General HospitalCompleted
-
Il-Yang Pharm. Co., Ltd.CompletedDrug Interaction PotentiationKorea, Republic of
-
Akebia TherapeuticsCompletedDrug Interaction PotentiationCanada
-
LEO PharmaCompletedDrug Interaction PotentiationGermany
-
Il-Yang Pharm. Co., Ltd.Severance HospitalCompletedDrug Interaction PotentiationKorea, Republic of
Clinical Trials on Midazolam
-
PfizerCompleted
-
Seattle Children's HospitalCompleted
-
Jiangsu HengRui Medicine Co., Ltd.CompletedGout and HyperuricemiaChina
-
Nourhan M.AlyAlexandria UniversityCompleted
-
Korea University Anam HospitalCompletedChild | Anesthesia Morbidity | Delirium on EmergenceKorea, Republic of
-
Hamad Medical CorporationCompleted
-
Second Affiliated Hospital of Wenzhou Medical UniversityRecruiting
-
University Hospital, Basel, SwitzerlandCompletedCytochrome P450 CYP3A Enzyme DeficiencySwitzerland
-
Ain Shams UniversityCompleted
-
Nourhan M.AlyCompleted