NCT02572349

Brief Summary

The objectives of the study are to assess the safety and tolerability of a range of single doses of IW-1701 when administered as oral capsules to healthy subjects, to determine the pharmacokinetic profile and pharmacodynamics effects of a range of single doses of IW-1701 when administered as oral capsules to healthy subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Oct 2015

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 8, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 3, 2019

Status Verified

April 1, 2019

Enrollment Period

2 months

First QC Date

October 7, 2015

Last Update Submit

April 1, 2019

Conditions

Healthy

Keywords

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

  • Assessment of the safety and tolerability of IW-1701 in healthy subjects via adverse events

    The primary objectives of this study are to assess the safety and tolerability of single ascending dosage levels of IW-1701 versus placebo in healthy subjects.

    From baseline up to 8 days

Study Arms (2)

IW-1701

EXPERIMENTAL

Single Dose

Drug: IW-1701

Matching Placebo for IW-1701

PLACEBO COMPARATOR

Single Dose

Drug: Matching Placebo

Interventions

IW-1701DRUG
IW-1701
Matching PlaceboDRUG
Matching Placebo for IW-1701

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Between 18 and 60 years old at the Screening Visit;
  • Women of childbearing potential must have a negative pregnancy test and must agree to use double-barrier contraception;
  • BMI \> 18.5 and \< 32.0 kg/m2 at the Screening Visit;
  • In overall good health with no clinically significant laboratory, ECG, or physical exam findings;

You may not qualify if:

  • History of any clinically-significant medical condition;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ironwood Investigational Site

San Antonio, Texas, 78209, United States

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2015

First Posted

October 8, 2015

Study Start

October 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

April 3, 2019

Record last verified: 2019-04

Locations

US(1)