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A Fixed-Sequence, Drug-Drug Interaction Study Between Multiple Oral Doses of Inarigivir Soproxil and a Single Oral Dose of Midazolam in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03493698
Recruitment Status : Completed
First Posted : April 10, 2018
Results First Posted : October 8, 2020
Last Update Posted : October 8, 2020
Sponsor:
Collaborator:
PRA Health Sciences
Information provided by (Responsible Party):
Spring Bank Pharmaceuticals, Inc.

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Drug Interaction Potentiation Drug: Midazolam Drug: Inarigivir Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 7, 2018
Actual Primary Completion Date : August 27, 2018
Actual Study Completion Date : August 27, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
Experimental: Treatment A: Midazolam
All subjects will receive a single oral dose of 2 mg Midazolam on Day 1
Drug: Midazolam
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
Drug: Inarigivir
Inarigivir
Other Name: Inarigivir Soproxil, SB 9200

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
Drug: Midazolam
Midazolam

Drug: Inarigivir
Inarigivir
Other Name: Inarigivir Soproxil, SB 9200




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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

  2. 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)

  3. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Gender : male or female
  2. Age : 18-55 years, inclusive, at screening
  3. Body mass index (BMI) : 18.0-30.0 kg/m2, inclusive, at screening
  4. Status : healthy subjects
  5. 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
  6. 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
  7. 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
  8. 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
  9. 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
  10. 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
  11. 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
  12. Willing and able to sign the ICF

Exclusion Criteria:

  1. Employee of PRA or the Sponsor
  2. History of relevant drug and/or food allergies
  3. Using tobacco products within 60 days prior to the first drug administration
  4. History of alcohol abuse or drug addiction (including soft drugs like cannabis products)
  5. 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
  6. 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)
  7. Positive screen for hepatitis B surface antigen (HBsAg), anti-HCV antibodies or anti-human immunodeficiency virus (HIV) 1 and 2 antibodies
  8. 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
  9. 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
  10. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03493698


Locations
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Netherlands
University Medical Center Groningen
Groningen, Netherlands
Sponsors and Collaborators
Spring Bank Pharmaceuticals, Inc.
PRA Health Sciences
Investigators
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Principal Investigator: Jeroen van de Wetering PRA Health Sciences
  Study Documents (Full-Text)

Documents provided by Spring Bank Pharmaceuticals, Inc.:
Study Protocol  [PDF] March 6, 2018
Statistical Analysis Plan  [PDF] July 2, 2018

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Responsible Party: Spring Bank Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03493698    
Other Study ID Numbers: SBP-9200-HBV-202
2018-000607-16 ( EudraCT Number )
First Posted: April 10, 2018    Key Record Dates
Results First Posted: October 8, 2020
Last Update Posted: October 8, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Midazolam
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action