ITF2984 Repeated Doses Study in Healthy Volunteers

Inclusion criteria

• Healthy Caucasian male volunteers between 18 and 50 years of age, inclusive.
• Body mass index (BMI) of 18 to 25 kg/m2 inclusive.
• Was willing and able to communicate and participate in the entire study.
• Had an understanding, ability and willingness to fully comply with study procedures and restrictions.
• Was willing and able to provide written, personally signed and dated informed consent to participate in the study, in accordance with the ICH GCP Guidelines and applicable regulations, before completing any study-related procedures.
• Agreed to comply with the applicable contraceptive requirements from admission to 90 days after the last dose.
• Had a satisfactory medical assessment with no clinically significant or relevant abnormalities in medical history, physical examination, vital signs, ECG or laboratory evaluation (haematology, biochemistry, urinalysis) as assessed by the investigator.

Exclusion criteria

• Current or recurrent disease (eg cardiovascular, respiratory, endocrine, renal, liver, GI, malignancy or other conditions) that could have affected the action, absorption or disposition of the IMP, or could have affected clinical or laboratory assessments.
• Current or relevant previous history of physical or psychiatric illness, any medical disorder that may have required treatment or made the subject unlikely to fully complete the study, or any condition that presented undue risk from the IMP or study procedures.
• Significant illness, as judged by the investigator, within 2 weeks of the first dose of IMP.
• Current use (defined as use within 14 days of first IMP dose) of any medication, including prescription, over-the-counter, herbal or homeopathic preparations (other than 4 g per day of paracetamol).
• Subjects who had received prohibited medication
• Known or suspected intolerance or hypersensitivity to the IMP, closely related compounds or any of the stated ingredients.
• History of alcohol or other substance abuse within the last year. A positive result for alcohol or drugs of abuse.
• Male subjects who consumed more than 21 units of alcohol per week or 3 units per day (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine).
• A positive human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab) test.
• Use of tobacco in any form (eg smoking or chewing) or other nicotine-containing products in any form (eg gum, patch). Ex-users had to report that they had stopped using tobacco for at least 90 days before receiving the first dose of IMP. A breath carbon monoxide (CO) reading of greater than 10 ppm at screening.
• Donation of blood or blood products (eg plasma or platelets) of greater than 400 mL within 90 days before receiving IMP.
• Use of another IMP within 90 days before receiving the first dose of IMP, or active enrolment in another drug or vaccine clinical study.
• Subjects who had previously been enrolled in this study.
• Clinically significant abnormal biochemistry, haematology or urinalysis result as judged by the investigator.
• Presence or history of allergy requiring treatment. Hayfever was allowed as long as it was inactive.
• Failure to satisfy the investigator of fitness to participate for any other reason.