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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02230228
Other study ID # ALK001-P1001
Secondary ID
Status Completed
Phase Phase 1
First received August 27, 2014
Last updated March 21, 2015
Start date April 2014
Est. completion date February 2015

Study information

Verified date March 2015
Source Alkeus Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This protocol is a phase 1 clinical study to assess the safety and pharmacokinetics of ALK-001 in healthy volunteers. Please contact trials@alkeus.com for any questions.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date February 2015
Est. primary completion date September 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 21 Years to 70 Years
Eligibility Main Inclusion Criteria

- Adult between 21 and 70 years old (inclusive)

- Healthy subject, as judged by investigator

- Subject is able and willing to comply with study requirements (study medication compliance, schedule of follow-up visits)

- Subject has provided informed consent to participate

- If female, subject uses a medically accepted birth control method and agrees to use such a method for entire clinical trial period

Main Exclusion Criteria:

- Subject has taken disallowed items during the past 30 days

- Female with a positive urine pregnancy test at screening

- Lactating woman

- Subject has participated in any clinical study involving an investigational drug, biologic or device, during the past 30 days

- History or current evidence of gastrointestinal malabsorption

- Subject has any other medical condition, which in the opinion of the investigator, is likely to prevent compliance with protocol and/or interfere with successful collection of study

- Subject has, in the opinion of investigator, clinically significant laboratory result(s), positive drug or alcohol screening, or ECG, which makes subject unsuitable for participation.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Intervention

Drug:
ALK-001 (No generic name)
Daily, oral administration of ALK-001 capsules.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Alkeus Pharmaceuticals, Inc.

Outcome

Type Measure Description Time frame Safety issue
Primary Safety of 4-week daily dosing of ALK-001 in healthy adults. Safety evaluations combine: adverse events (AE), laboratory testing (hematology and biochemistry panels), 12-lead electrocardiograms (ECGs), vital signs, physical examination, and visual function (visual acuity and a self-reported questionnaire). 4 weeks No
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