QCL-105482

• Research type

  Research Study

• Full title

  An Exploratory Early Phase 1, Randomized, Double-Blind, Placebo-Controlled, Sequential-Panel, Ascending Single-Dose Study of T-3076074 to Evaluate Its Pharmacokinetic and Safety Profile in Healthy Male Subjects

• IRAS ID

  50251

• Contact name

  Stuart J Mair

• Sponsor organisation

  Takeda Global Research and Development Centre (Europe) Ltd.

• Eudract number

  2010-019286-28

• Research summary

  The drug that is under investigation during this study is T-3016074 and is expected to be developed as a treatment for patients suffering from high blood pressure. The main purpose of this study is to investigate the safety of and the ability of the body to tolerate single doses of T-3016074 and to measure the amount of T-3016074 in blood. The absorption (how the body takes up the drug), breakdown and elimination (how the body gets rid of the drug) of a single dose of radiolabelled T-3016074 and its breakdown products will also be defined in one of the 4 groups of volunteers by measuring the amount of drug in blood, urine and faeces over an 8 day period. The design includes 4 groups, where each group will consist of 8 volunteers; Within each group, 6 volunteers will be randomly assigned to receive a single oral dose of T-3016074 and 2 will be randomly assigned to receive placebo. Volunteers will receive a single oral dose of T-3016074 on Day 1 and will be discharged from the unit on Day 8. Volunteers will be contacted on Day 14 (ñ2 days) for a Follow Up phone call. All doses will be administered on Day 1 in a fasted state. It is planned that each ascending dose will be administered in a staggered dose design with 2 volunteers being dosed 2 days in advance of the other 6. The data from the 2 volunteers dosed first will be reviewed prior to dosing the next 6. All groups will be split into 2 sub-groups; in group Xa, 1 volunteer will receive T-3016074, and 1 volunteer will receive placebo. In group Xb, 5 volunteers will receive T-3016074, and 1 volunteer will receive placebo. It is proposed that in group 3 (3a/3b), a trace amount of radiolabelled T-3016074 will be administered.

• REC name

  Scotland A REC

• REC reference

  10/IEC02/8

• Date of REC Opinion

  21 Apr 2010

• REC opinion

  Further Information Favourable Opinion