Assessing in a sequential manner, the safety, tolerability and pharmacokinetics of multiple formulations of CTP-730 in healthy volunteers

A Two-Part Study of the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Immediate and Delayed Release Formulations of CTP-730 in Healthy Volunteers.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615000511538

Enrollment

Registered

2015-05-22

Start date

2015-04-08

Completion date

2015-06-24

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study will assess consecutively the safety, tolerability, and pharmacokinetics of single and multiple doses of CTP-730 in healthy volunteers.

Interventions

Drug: CTP-730 Drug: Placebo for CTP-730 Part 1: Four (4) dose/formulation combinations in total will be studied, with the first 3 formulations studied in a 3-period randomized, double-blind crossover fashion and the 4th formulation (a composite formulation, determined based on outcomes from the crossover) will not be randomized. 40mg will be administered once a day for Part 1. Part 1 subjects will receive a single dose of CTP-730 in the morning following an overnight fast. Subjects will remain sequestered at the site until the last PK blood sample is collected at 48 hours post dose. Part 2: A multi-dose exploration of the composite formulation of CTP-730 selected from Part 1, for 7-days. Up to 80mg will be administered once a day for 7 days. The dose to be administered in Part 2 will be determined based on information obtained from Part 1 of the study. A single dose of the composite formulation will be administered daily for a total of 7 days. Drug will be in the form of oral capsules. Pharmacokinetic blood samples will be taken to monitor adherence to the intervention. There is a 7 day washout period between each period in Part 1.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

1. Healthy adult males and females between 18 and 50 years of age. 2. Body weight >/= 50 kg and BMI within the range of 18 to 30 kg/m2.

Exclusion criteria

1. Medical, psychiatric illness or history of depression that could, in the investigator’s opinion, compromise the subject’s safety. 2. Significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study. 3. History of clinically significant central nervous system (eg, seizures), cardiac, pulmonary, metabolic, renal, hepatic, or gastrointestinal (GI) conditions. 4. PR interval >/= 220 msec or QRS duration >/= 120 msec or QTcB / QTcF interval > 450 msec obtained at screening visit or prior to the first dose of study drug. 5. Liver function tests greater than the upper limit of normal. 6. Positive screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen, or hepatitis C virus antibody at screening. 7. Urinalysis positive for protein or glucose. 8. A positive screen for alcohol, drugs of abuse, or tobacco use. 9. Inability to comply with food and beverage restrictions during study participation. 10. Donation or blood collection or acute loss of blood prior to screening.

Outcome results