A Pharmacokinetics Study of AF-130 in Healthy Subjects

NCT02652936 | Completed Phase 1

• 2 other identifiers: 1112-001AF130-001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This is a 2-part, single centre, single (Part 1) and multiple (Part 2) dose escalation study in healthy male subjects.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• Number of subjects with treatment-related adverse events following a single oral dose of AF-130

  48 hours

• Number of subjects with treatment-related adverse events following multiple oral doses of AF-130

  7 days

Secondary Outcomes (2)

• Maximum plasma concentration (Cmax) profile of an oral formulation of AF-130

  48 hours

• Maximum plasma concentration (Cmax) profile of an oral formulation of AF-130

  multiple daily timepoints over 7 days

Study Arms (2)

AF-130 capsule

EXPERIMENTAL

AF-130 oral capsules administered as a single dose or once daily for 7 days

Drug: AF-130

AF-130 matching placebo capsule

PLACEBO COMPARATOR

Oral placebo capsules to match AF-130 administered as a single dose or once daily for 7 days

Drug: Placebo comparator

Interventions

AF-130 DRUG

AF-130 oral capsules (50 mg) administered as a single dose or once daily for 7 days

AF-130 capsule

Placebo comparator DRUG

AF-130 matching placebo capsule

AF-130 matching placebo capsule

Eligibility Criteria

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

You may qualify if:

• Healthy males
• Age 18 to 55 years
• Body mass index of 18.0 to 35.0 kg/m2
• Willing and able to communicate and participate in the whole study
• Must provide written informed consent
• Must agree to use an adequate method of contraception

You may not qualify if:

• Participation in a clinical research study within the previous 3 months
• Subjects who are study site employees, or immediate family members of a study site or sponsor employee
• Subjects who have previously been enrolled in this study
• History of any drug or alcohol abuse in the past 2 years
• Regular alcohol consumption \>21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
• Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening
• Subjects who do not have suitable veins for multiple venepunctures/cannulation
• Clinically significant abnormal biochemistry, haematology or urinalysis
• Positive drugs of abuse test result
• Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
• History of cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease as judged by the investigator
• QT interval corrected for heart rate using Fridericia's formula (QTcF) \>450 ms at screening and pre-dose
• Gastric or intestinal surgery, except for fully healed appendectomy and/or cholecystectomy
• Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
• Presence or history of clinically significant allergy requiring treatment

Sponsors & Collaborators

• Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA): lead

Study Sites (1)

Quotient Clinical

Ruddington, Nottingham, NG11 6JS, United Kingdom

Location

Study Officials

• Afferent Pharmaceuticals

  Afferent Pharmaceuticals Clinical Research

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: January 8, 2016
• First Posted: January 12, 2016
• Study Start: October 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: December 6, 2016

Record last verified: 2016-12

Locations

GB (1)