A Single Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of Orally Administered DAA-I in Healthy Subjects

NCT02666196 | Completed Phase 1 DMC

• 1 other identifier: DAA-I
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a placebo-controlled randomized phase 1 study to investigate the safety and pharmacokinetics of DAA-I in a cohort of healthy subjects.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Evaluate the safety and dose range of DAA-I after single oral dose administration

  Evaluate the safety (in terms of effect on normal blood pressure, pulse, and 12-lead ECG) of DAA-I following a single oral administration in 12 healthy subjects (0.08 mg/kg/subject in 4 subjects, 0.7 mg/kg/subject in 4 subjects, and 1.5 mg/kg/subject in 4 subjects).

  24 hours

Secondary Outcomes (1)

• Evaluate the pharmacokinetics of DAA-I after single oral dose administrations

  24 hours

Study Arms (4)

DAA-I 6mg

EXPERIMENTAL

Subjects given solid compound in vials containing 6mg per vial

Drug: DAA-I

DAA-I 50mg

EXPERIMENTAL

Subjects given solid compound in vials containing 50mg per vial

Drug: DAA-I

DAA-I 110mg

EXPERIMENTAL

Subjects given solid compound in vials containing 110mg per vial

Drug: DAA-I

Placebo

PLACEBO COMPARATOR

Subjects given 25ml placebo dissolved in 200ml water

Drug: Placebo

Interventions

DAA-I DRUG

DAA-I 110mg; DAA-I 50mg; DAA-I 6mg

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Overtly healthy males or females as determined by medical history and physical examination.
• Between the ages of 21 and 50 years, inclusive.
• Weight limits within range of Body Mass Index (BMI) 19-30kg/m2
• Renal, hepatic and blood chemistry results within normal range.
• Normal blood pressure and heart rate as determined by the investigator.(Normal range: Systolic BP 100-140mmHg;Diastolic BP 40-90mmHg; Heart rate 50 - 100 beats per minute)
• Temperature between 36oC to 37.4oC
• Electrocardiogram considered as within normal limits by the investigator.
• Are reliable and willing to make themselves available for the duration of the study.
• Ability to provide informed consent.

You may not qualify if:

• History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, neurological disorders capable of altering the absorption, metabolism or elimination of drugs, or of constituting a risk factor when taking the study medication.
• Evidence of significant active haematologic disease and/or blood donation in the last 3 months.
• Are pregnant or intend to become pregnant during the course of the study.
• Sexually active women of childbearing age not actively practising birth control by using oral contraceptives or an intrauterine device (IUD).
• Women who are lactating.
• History of allergic reactions to angiotensin inhibitor (AI), angiotensin II inhibitors, DAA-I or other relevant allergic reactions of any origins.
• Participation in a study involving administration of an investigational compound within the past 30 days.

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Related Publications (1)

• Lee KO, Khoo CM, Chowbay B, Chan YH, Sim MK. A Single Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of Orally Administered Des-Aspartate Angiotensin I in Healthy Subjects. Drugs R D. 2016 Dec;16(4):317-326. doi: 10.1007/s40268-016-0143-y.

  PMID: 27681888 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Lee Kok Onn, Senior Consultant

Study Record Dates

• First Submitted: December 14, 2015
• First Posted: January 28, 2016
• Study Start: September 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 28, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share