TD-6450 SAD and MAD in Healthy Subjects

NCT02022306 | Completed Phase 1

• 1 other identifier: 0094
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

This study consists of two parts, Parts A and B. Part A is a single ascending dose (SAD) study in healthy subjects. Part B is a multiple ascending dose (MAD) study in healthy subjects.

Conditions

Hepatitis C

Keywords

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Adverse events

  28 days max

Secondary Outcomes (5)

• Cmax

  28 days max

• Tmax

  28 days max

• AUC

  28 days max

• T1/2

  28 days max

• Food effect on AUC value

  15 days max

Study Arms (3)

SAD TD-6450

PLACEBO COMPARATOR

Single ascending dose (Part A)

Drug: TD-6450; Drug: Placebo

MAD TD-6450

PLACEBO COMPARATOR

Multiple ascending dose (Part B)

Drug: TD-6450; Drug: Placebo

Food effect of TD-6450

ACTIVE COMPARATOR

Food effect will be assessed in Part A (SAD) of this study.

Drug: TD-6450

Interventions

TD-6450 DRUG

Food effect of TD-6450; MAD TD-6450; SAD TD-6450

Placebo DRUG

MAD TD-6450; SAD TD-6450

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject is a female of non-childbearing potential or male, who is healthy, nonsmoking, and 18 to 60 years old, inclusive, at screening. Females are considered to be of non childbearing potential if they have had a hysterectomy or tubal ligation (documentation required) or are postmenopausal (amenorrheic for at least 2 years) with a follicle stimulating hormone (FSH) level \>40 IU/L
• Subject has a body mass index 18 to 30 kg/m2, inclusive, and weighs at least 50 kg.

You may not qualify if:

• Subject has evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease.
• Subject has an estimated creatinine clearance of \<90 mL/min at Screening or Day -1, calculated using the Cockcroft-Gault equation.
• Subject has participated in another clinical trial of an investigational drug (or medical device) within 60 days prior to Screening, or is currently participating in another trial of an investigational drug (or medical device).

Sponsors & Collaborators

• Theravance Biopharma: lead

Study Sites (1)

ICON Development Solutions

San Antonio, Texas, 78209, United States

Location

Related Publications (1)

• Carucci M, Duez J, Tarning J, Garcia-Barbazan I, Fricot-Monsinjon A, Sissoko A, Dumas L, Gamallo P, Beher B, Amireault P, Dussiot M, Dao M, Hull MV, McNamara CW, Roussel C, Ndour PA, Sanz LM, Gamo FJ, Buffet P. Safe drugs with high potential to block malaria transmission revealed by a spleen-mimetic screening. Nat Commun. 2023 Apr 7;14(1):1951. doi: 10.1038/s41467-023-37359-2.

  PMID: 37029122 DERIVED

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Medical Monitor

  Theravance Biopharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2013
• First Posted: December 27, 2013
• Study Start: February 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: September 1, 2014
• Last Updated: January 14, 2021

Record last verified: 2021-01

Locations

US (1)