NCT01952548

Brief Summary

This study will test single doses of the study drug in increasing amounts to see if it is safe.

Trial Health

80
On Track

Trial Health Score

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

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 30, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Last Updated

December 31, 2013

Status Verified

December 1, 2013

Enrollment Period

7 months

First QC Date

September 19, 2013

Last Update Submit

December 30, 2013

Conditions

Safety and Tolerability

Outcome Measures

Primary Outcomes (1)

  • Adverse Events

    10 Days

Study Arms (14)

Dose 1 Active

EXPERIMENTAL
Drug: K-312

Dose 2 Active

EXPERIMENTAL
Drug: K-312

Dose 3 Active

EXPERIMENTAL
Drug: K-312

Dose 4 Active

EXPERIMENTAL
Drug: K-312

Dose 5 Active

EXPERIMENTAL
Drug: K-312

Dose 6 Active

EXPERIMENTAL
Drug: K-312

Dose 7 Active

EXPERIMENTAL
Drug: K-312

Dose 1 Placebo

PLACEBO COMPARATOR
Drug: Placebo

Dose 2 Placebo

PLACEBO COMPARATOR
Drug: Placebo

Dose 3 Placebo

PLACEBO COMPARATOR
Drug: Placebo

Dose 4 Placebo

PLACEBO COMPARATOR
Drug: Placebo

Dose 5 Placebo

PLACEBO COMPARATOR
Drug: Placebo

Dose 6 Placebo

PLACEBO COMPARATOR
Drug: Placebo

Dose 7 Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

K-312DRUG
Dose 1 ActiveDose 2 ActiveDose 3 ActiveDose 4 ActiveDose 5 ActiveDose 6 ActiveDose 7 Active
PlaceboDRUG
Dose 1 PlaceboDose 2 PlaceboDose 3 PlaceboDose 4 PlaceboDose 5 PlaceboDose 6 PlaceboDose 7 Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Age GroupsAdult (18-64)

You may qualify if:

  • Subject provides written informed consent before any study-specific evaluation is performed.
  • Subject is a healthy adult male or a female of non-childbearing potential between the ages of 18 and 45 years, inclusive.
  • Subject has a body mass index of 18.5 to 32 kg/m2, inclusive.

You may not qualify if:

  • Subject is a woman who is of childbearing potential or is breastfeeding.
  • Subject has the presence of an active or recurring clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal, or metabolic disease requiring medical treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Austin, Texas, United States

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2013

First Posted

September 30, 2013

Study Start

May 1, 2013

Primary Completion

December 1, 2013

Last Updated

December 31, 2013

Record last verified: 2013-12

Locations

US(1)