A Pharmacokinetics Study of AF-130 in Healthy Subjects

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

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: AF-130

Drug: Placebo comparator

Study type

Interventional

Funder types

Industry

Identifiers

NCT02652936

AF130-001 (Other Identifier)

1112-001

Details and patient eligibility

About

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

Full description

Part 1 is a double-blind, placebo-controlled, randomised single dose design in up to 64 healthy male subjects. Part 1 will consist of Groups 1 to 6, each comprising 8 subjects (total of 48 subjects). There will be an option to enrol 2 additional groups (8 subjects in each of Groups 7 and 8) to assess alternative dose levels. Subjects will be randomised to receive active or placebo in the fasted state.

Part 2 is a double-blind, placebo-controlled, randomised, multiple ascending dose design in up to 45 healthy male subjects. Part 2 will consist of Groups 9 to 11, each comprising 9 subjects (total of 27 subjects). There will be an option to enrol 2 additional groups (9 subjects in each of Groups 12 and 13) to assess alternative multiple dose levels. Part 2 will not commence before completion of Groups 1 to 3 in Part 1. Subjects will be randomised to receive active or placebo in the fasted state. The planned dosing regimen is once per day however, this may be modified to twice per day depending on emerging pharmacokinetic data from Part 1.

Enrollment

80 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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
Ingestion of grapefruit or grapefruit juice within 48 h before dose administration
Donation or loss of greater than 400 mL of blood within the previous 3 months
Subjects who are taking, or have taken, any prescribed or over-the-counter drug (other than 4 g per day paracetamol) or herbal remedies in the 14 days before study drug administration
Receipt of an investigational product or device, or participation in a drug research study within a period of 30 days (or 5 half-lives, whichever is longer) before the first dose of study medication
Receipt of an investigational immunomodulator or monoclonal antibody within 180 days (or 5 half-lives, whichever is longer) before the first dose of study medication
Failure to satisfy the investigator of fitness to participate for any other reason