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

NCT01705938 | Completed Phase 1

• 1 other identifier: SP333101
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Exposure

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with treatment emergent adverse events as a measure of safety and tolerability

  14 days

Secondary Outcomes (1)

• Area under the plasma concentration versus time curve (AUC) of SP-333 following single oral doses of tablets.

  48 hours

Study Arms (7)

Group 1

ACTIVE COMPARATOR

SP-333 0.1 mg \& Placebo, one tablet by mouth, single dose

Drug: SP-333

Group 2

ACTIVE COMPARATOR

SP-333 0.3 mg \& Placebo, 3 tablets by mouth, single dose

Drug: SP-333

Group 3

ACTIVE COMPARATOR

SP-333 1 mg \& Placebo, one tablet by mouth, single dose

Drug: SP-333

Group 4

ACTIVE COMPARATOR

SP-333 3 mg \& Placebo, 3 tablets by mouth,single dose

Drug: SP-333

Group 5

ACTIVE COMPARATOR

SP-333 10 mg \& Placebo, 1 tablet by mouth, single dose

Drug: SP-333

Group 6

ACTIVE COMPARATOR

SP-333 30 mg \& Placebo, 3 tablets by mouth, single dose

Drug: SP-333

Group 7

ACTIVE COMPARATOR

SP-333 60 mg \& Placebo, 6 tablets by mouth, single dose

Drug: SP-333

Interventions

SP-333 DRUG

Group 1; Group 2; Group 3; Group 4; Group 5; Group 6; Group 7

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female subjects between 18 and 55 years old
• 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
• Medically healthy with no clinically significant findings.
• Subjects must have bowel habits that are considered regular (for this study a minimum of 4 bowel movements a week without laxatives).
• Subject must have had a bowel movement, without laxatives, in the 3 days before administration of study drug.
• Male subjects with female sexual partners of child-bearing potential must agree to use highly effective contraceptive methods during the study.
• Female subjects must be post-menopausal and not pregnant.
• Subjects must understand and agree to comply with the requirements of the study and they must be willing to sign an Informed Consent Form.

You may not qualify if:

• Smokers or users of nicotine products who do not agree to not smoke or use nicotine products during their stay in the CPU.
• 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.
• Presence of any abnormal clinically significant laboratory.
• History of any serious allergic reaction to any medication
• Certain abnormalities of the ECG.
• Participated in a previous clinical study with an investigational product within 30 days of study Participation
• Donated blood, blood components or significant loss of blood within 2 months of dosing
• History of a clinically-significant illness within 4 weeks of dosing
• 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
• History of clinically-significant drug or alcohol abuse within 2 years of study participation
• Positive urine screen for prohibited drugs (cocaine, cannabinoids, opiates, barbiturates, amphetamines, benzodiazepines, phencyclidine, propoxyphene).
• History of human immunodeficiency virus (HIV), hepatitis B surface antigen positive (+HBsAg), or hepatitis C antibody positive (+HCVAb).
• 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)

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (1)

Anaheim Clinical Trials

Anaheim, California, 92801, United States

Location

MeSH Terms

Interventions

dolcanatide

Study Officials

• Peter Winkle, MD

  Anaheim Clinical Trials

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2012
• First Posted: October 12, 2012
• Study Start: October 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 24, 2019

Record last verified: 2019-05

Locations

US (1)