Bioavailability of ABT-450 and ABT-267 With Ritonavir

Absolute Bioavailability Clinical Trial

Official title:

A Phase I, Open-Label, Single Centre Study Designed to Determine the Absolute Bioavailability of ABT-450 (150 mg) and ABT-267 (25 mg) When Administered as an Oral Co-Formulated Product With Ritonavir (100 mg), ABT 450/r/ABT 267, to Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02052362
• Other study ID #: M14-229
• Secondary ID: 2013-003685-14
• Status: Completed
• Phase: Phase 1
• First received: January 30, 2014
• Last updated: February 17, 2014
• Start date: January 2014
• Est. completion date: February 2014

Study information

• Verified date: February 2014
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

A study to investigate the fraction of ABT-267 and ABT-450 absorbed by the body when given in combination with each other and Ritonavir(r).

Description:

Absolute bioavailability of ABT-267 and ABT-450 in the body when given together

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Healthy males or non-pregnant, non-lactating healthy females

2. Body mass index of 18.0 to 30.0 kg/m2

3. Must be willing and able to communicate and participate in the whole study

4. Must provide written informed consent

5. Must agree to use an adequate method of contraception

6. In a condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG

Exclusion Criteria:

1. Participation in a clinical research study within the previous 3 months or in an absorption, distribution, metabolism, and excretion (ADME) study within the previous 12 months

2. History of any drug or alcohol abuse in the past 2 years or current smokers and those who have smoked within the last 12 months or a positive cotinine urine test at screening and admission

3. Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study

4. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results

5. Donation or loss of greater than 550 mL of blood (including plasmapheresis) or receipt of a transfusion of any blood product within the previous 8 weeks

6. Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies within the 14 days or any drug by injection (including vaccines) within 30 days or within 10 half-lives of the respective medication, whichever is longer, before Investigational Medical Product (IMP) administration

Study Design

Allocation: Non-Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Absolute Bioavailability

Intervention

Drug:
• ABT-450/r/ABT-267
ABT-450, ABT-267 and ritonavir

Locations

Country	Name	City	State
United Kingdom	Site Reference ID/Investigator# 118615	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute bioavailability	dose normalized AUC(0-inf) for oral dose/dose normalized AUC(0-inf) for IV dose	Day 1 until 72 hours after single dose of ABT-450/r/ABT-267	No
Secondary	Safety Labs	Chemistry, Haematology, Urinalysis	Day -1 until 72 hours after single dose of ABT-450/r/ABT-267	Yes
Secondary	Electrocardiograms (ECGs)	The measure of any change in 12 lead electrocardiogram from Day-1	Day-1 until 24 hours after single dose of ABT-450/r/ABT-267	Yes
Secondary	Number of participants with adverse events		Screening until 7 days after single dose of ABT-450/r/ABT-267	Yes
Secondary	Physical Exam	To examine any change from Day-1 in the subject's physical presentation (body temperature, blood pressure, pulse)	Day-1 until 72 hours after single dose ABT-450/r/ABT-267	Yes