Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of SP-333 Tablets in Healthy Adult Subjects

May 23, 2019 updated by: Bausch Health Americas, Inc.

A First In Human, Single Blind, Placebo Controlled, Randomized Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SP-333 Tablets in Healthy Adult Subjects

This is a randomized, phase 1, single-blind, placebo-controlled, randomized, sequential, escalating, single-dose, study designed to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) properties of orally administered SP-333 tablets.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a randomized, phase 1, single-blind, placebo controlled, single-dose, study designed to evaluate the safety, tolerability, and pharmacokinetic properties of orally administered SP-333 tablets. The study will include 7 groups of 8 subjects each (6 active, 2 placebo) given a single oral dose of of SP-333 tablets or placebo. Following outpatient screening from approximately 5 to 42 days before dosing, each subject will enter the Clinical Pharmacology Unit (CPU) and will be housed from at least 48 hours, before dosing until 48 hours after dosing. Subjects will be given single dose of the study drug on the day of dosing and remain in the CPU for at least 48 hours. Subjects will return to the CPU on Days 8±1 and 15±1 for safety follow up. Safety Committee Meetings will be conducted to review safety, tolerability, and available Pharmacokinetic data from the current and previous treatment group(s), prior to dosing subsequent treatment groups. Subjects in a given treatment group are considered completers once they have completed the Day 15±1 day Follow up Visit.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • California
      • Anaheim, California, United States, 92801
        • Anaheim Clinical Trials

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female subjects between 18 and 55 years old
  2. Body weight greater than or equal to 50 kg (110 pounds) and Body Mass Index (BMI) in the range of 18 to 30 kg/ m2
  3. Medically healthy with no clinically significant findings.
  4. Subjects must have bowel habits that are considered regular (for this study a minimum of 4 bowel movements a week without laxatives).
  5. Subject must have had a bowel movement, without laxatives, in the 3 days before administration of study drug.
  6. Male subjects with female sexual partners of child-bearing potential must agree to use highly effective contraceptive methods during the study.
  7. Female subjects must be post-menopausal and not pregnant.
  8. Subjects must understand and agree to comply with the requirements of the study and they must be willing to sign an Informed Consent Form.

Exclusion Criteria:

  1. Smokers or users of nicotine products who do not agree to not smoke or use nicotine products during their stay in the CPU.
  2. Current or history of clinically significant diseases, including gastrointestinal, renal, hepatic, neurologic (e.g., neuropathy), hematologic, endocrine (e.g., diabetes), oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition.
  3. Presence of any abnormal clinically significant laboratory.
  4. History of any serious allergic reaction to any medication
  5. Certain abnormalities of the ECG.
  6. Participated in a previous clinical study with an investigational product within 30 days of study Participation
  7. Donated blood, blood components or significant loss of blood within 2 months of dosing
  8. History of a clinically-significant illness within 4 weeks of dosing
  9. Special diet, any dietary habits, or restrictions, which, may interfere with conduct of the study or health of the subject within 30 days of dosing
  10. History of clinically-significant drug or alcohol abuse within 2 years of study participation
  11. Positive urine screen for prohibited drugs (cocaine, cannabinoids, opiates, barbiturates, amphetamines, benzodiazepines, phencyclidine, propoxyphene).
  12. History of human immunodeficiency virus (HIV), hepatitis B surface antigen positive (+HBsAg), or hepatitis C antibody positive (+HCVAb).

  13. History of certain surgeries:

    • Gastric bypass surgery or invasive procedure for the treatment of obesity or surgery to remove a segment of the gastrointestinal (GI) tract at any time.
    • Patients who have had a gastric band (unless the band has been completely removed for more than 60 days)
    • Surgery of the abdomen, pelvis or retroperitoneal structures within six months of study participation.
    • Appendectomy,Instrumentation of the bowel, major surgery within 60 days of study participation.
  14. Female subjects of childbearing potential or who are breastfeeding
  15. Use of any routine systemic medication, including any over the counter (OTC) medication within 2 weeks of dosing
  16. Use of herbal products, dietary supplements, vitamins, grapefruit, or grapefruit containing products within 2 weeks of dosing
  17. Irregular daily bowel habits
  18. Any other issue which, in the judgment of the investigator, will make the subject ineligible for study participation

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: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Group 1
SP-333 0.1 mg & Placebo, one tablet by mouth, single dose
Drug: SP-333
Active Comparator: Group 2
SP-333 0.3 mg & Placebo, 3 tablets by mouth, single dose
Drug: SP-333
Active Comparator: Group 3
SP-333 1 mg & Placebo, one tablet by mouth, single dose
Drug: SP-333
Active Comparator: Group 4
SP-333 3 mg & Placebo, 3 tablets by mouth,single dose
Drug: SP-333
Active Comparator: Group 5
SP-333 10 mg & Placebo, 1 tablet by mouth, single dose
Drug: SP-333
Active Comparator: Group 6
SP-333 30 mg & Placebo, 3 tablets by mouth, single dose
Drug: SP-333
Active Comparator: Group 7
SP-333 60 mg & Placebo, 6 tablets by mouth, single dose
Drug: SP-333

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percentage of participants with treatment emergent adverse events as a measure of safety and tolerability
Time Frame: 14 days
14 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Area under the plasma concentration versus time curve (AUC) of SP-333 following single oral doses of tablets.
Time Frame: 48 hours
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bausch Health Americas, Inc.

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 8, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 12, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 24, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SP333101

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.

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