Phase 1 Safety Study of ALK-001 in Healthy Volunteers

Age-related Macular Degeneration Clinical Trial

Official title:

A Phase 1, Open Label, Repeat Dose Study to Investigate the Safety and Pharmacokinetics of 4-week Daily Dosing of ALK-001 in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02230228
• Other study ID #: ALK001-P1001
• 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

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Macular Degeneration
• Other Retinal Dystrophies
• Retinal Dystrophies
• Stargardt Disease

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