QCL-1339

• Research type

  Research Study

• Full title

  An Exploratory Phase 1, Randomized, Double-Blind, Placebo- Controlled, Sequential-Panel, Ascending Single Dose Study Of T-1810021 To Evaluate Its Pharmacokinetic And Safety Profile In Healthy Male Subjects. Study No: QCL 1339

• IRAS ID

  43027

• Contact name

  Stuart J Mair

• Sponsor organisation

  Takeda Global Research and Development

• Eudract number

  2009-017456-27

• Research summary

  The drug that's under investigation during this study is T-1810021 and is expected to be used as a treatment for patients suffering from high blood pressure.The main purpose of this study is to investigate the safety and tolerability of single doses of T-1810021 and to measure the amount of T-1810021 in blood. The absorption (how the body takes up the drug), breakdown and elimination (how the body gets rid of the drug e.g., in urine, faeces etc) of a single dose of radiolabelled T-1810021 and its breakdown products will also be defined in one of the 4 groups of subjects by measuring the amount of drug in blood, urine and faeces over an 8 day period. The design includes 4 cohorts, where each cohort will consist of 8 subjects; Within each cohort, 6 subjects will be randomized to receive a single oral dose of T-1810021 and 2 will be randomized to receive placebo. Subjects will receive a single oral dose of T-1810021 on Day 1 and will be discharged from the unit on Day 8. Subjects will be contacted on Day 14 ( 2 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 subjects being dosed 2 days in advance of the other 6. The data from the 2 subjects dosed will be reviewed prior to dosing the next 6. All groups will be split into 2 sub-cohorts; in cohort Xa, 1 subject will receive T-1810021, and 1 subject will receive placebo. In cohort Xb, 5 subjects will receive T-1810021, and 1 subject will receive placebo.It is proposed that in cohort 3 (3a/3b), a trace amount of radiolabelled T-1810021 will be administered.

• REC name

  Scotland A REC

• REC reference

  09/IEC02/30

• Date of REC Opinion

  25 Jan 2010

• REC opinion

  Favourable Opinion